Delivering a World-Class Customer Experience. roduct Catalo

Transcription

1 Delivering a World-Class Customer Experience roduct Catalo International Product Catalog

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3 Welcome to MedTest s International Catalog Welcome to MedTest s international catalog. This catalog provides valuable information on all our products and services offered outside of the United States and Canada. I hope you find the breadth and depth of the resources supporting our international customers and partners are meeting your needs. We Understand That You Are Counting On Us Today s global healthcare industry is changing every day. Industry reform, financial pressures, political uncertainties, and advances in medicine and technology all continue to impact and fundamentally change how diagnostic products and services are delivered on a global scale. Clinical laboratories of all types continue to be challenged by complexity and uncertainty every day. These laboratories depend on MedTest to deliver solutions that will help them achieve their laboratory goals. MedTest solutions help these clinical laboratories save time and money, and make laboratory life easier! Delivering a World-Class Customer Experience MedTest is excited to bring together three high quality brands, Pointe Scientific, MedTest DX, and Clinitox Diagnostix, to broaden its product offerings to better meet your clinical laboratory needs. With 30 years of rich history and experience in developing, manufacturing, servicing and supporting its products, MedTest will continue to rapidly deliver high quality, cost-effective, easy-to-use, products, while providing the highest level of service and support to the international clinical diagnostics industry. Together with my entire team, I am committed to providing you with the assistance and support you require. You can contact my office at any time with requests, comments, questions, issues or concerns at hryu@medtest.com. Sincerely, Hanjoon Ryu Chief Executive Officer The Pointe Scientific brand of international products and services included in this international catalog are ones which, on the basis of information available at the time of publication, are current and accurate. For the most up to date information on all products, programs, announcements, product releases, and upcoming events, please visit our website at 03

4 Table Of Contents Analyzers Pointe Pointe 180 II Pointe 180 QT Pointe 180 Impulse TM Pointe c Instrument Specific Reagents Beckman Coulter AU Hitachi Mindray BS Diagnostic Reagents Chemistry Reagents Large Volume Packaging Enzyme Immunoassays (EIA) Fertility Tests Other Analytes Steroid Tests Thyroid Tests ToRCH Panel Tumor Markers Calibrators/Standards Calibrators Standards Quality Control General Chemistry Controls Specialty Controls Urine Chemistry Controls

5 07 08 Consumables OEM/B2B Partnership Program Beckman Coulter Bulk Products General Laboratory Contract Manufacturing Hitachi Private Label Pointe 180 Series

6 Analyzers Analyzers Pointe Pointe 180 II Pointe 180 QT Pointe 180 Impulse TM Pointe c

7 Pointe 180 Catalog: 90.P Analyzers The Pointe 180 is a small, semi-automated chemistry analyzer with six filters and a large test menu. It has an onboard incubator with 12 wells at 37 C, a temperature controlled cuvette well, and internal temperature control. The analyzer leads the user through test performance in a step-by-step manner. The new graphics software allows extended timed absorbance interval data and kinetic data plots to be printed. The analyzer has 48 programmed and 21 open channels, and reads, calculates, and prints results in less than three seconds. The analyzer reads test tubes upon insertion----no need to press a button. Optimized parameters for Pointe Scientific reagents are already entered - just select the test number. Open channels are available for programming other tests. The normal range for each test is automatically printed out, and results that are out of the normal range are flagged. Normal ranges can be edited to fit the area or population. Results generated by the Pointe 180 are comparable to results reported by hospital and reference labs. The analyzer can use single point calibration by standard/factor, multi-point calibration with point to point curve fit, percent absorbance and rate by standard or factor. These calculation options allow the analyzer to perform endpoint, initial rate, kinetic rate and batch kinetic methodologies. Specifications Specifications Linear Measurement Range: 0.0 to 2.50 Absorbance Units (A) Display: Alphanumeric, 16 character, LCD Photometric Accuracy: ± (1% of the reading A) at 1.5A ± (2% of the reading A) at 1.5-2A Light Source: Wavelengths: Typical Half Bandpass: Type of Filter: Tube Minimum Fill Volume: Maximum Fill Volume: Temperature: Tungsten Halogen Lamp 340, 405, 450, 490, 550, 600 nm 10 nm Multiple-cavity sealed interference 12 mm round standard 1 ml 2 ml (for temperature control to 37 C only) 37 C (±0.3 ), Block stays on, Cell has on/off switch Printer: Keyboard: Thermal, dot matrix, 20 characters per line 16 key, membrane switch, 4X4, audible response Calculation modes: Single point calibration by standard or factor Multipoint calibration with point to point curve fit Multipoint percent absorbance rate standard or factor (batch or single) Fixed time kinetic Fuse requirements: 120VAC A, 3AG slo blo Power: Switch selectable power supply (115V or 230V indicated) Voltage Source: / VAC from 50 to 60 Hz Installation Category: CAT II Power consumption: 45 Watts Fuse: Two 0.6A, T rating, 250V slo blo, 3AG type fuses All power cords must be approved for the country of use Lamp saver time: After 15 minutes idle Dimensions: 9.5 X X 3.75 inches (24 X 34 X 10 cm) Speed: Reads, calculates and prints results in 3 seconds Weight: Approximately 10 lbs (4.5 Kg) 07

8 Analyzers Pointe 180 II * Catalog: 90.P The Pointe 180 II is a small bench top analyzer designed to read and calculate the results of in-vitro clinical diagnostic assays on human serum, plasma, or urine as well as any other application requiring absorbance or concentration readings. The analyzer is provided with 43 pre-programmed test parameters and is capable of storing up to 120 assays in memory for later recall. The analyzer is equipped with a built in vacuum pump and external waste bottle with level sensing. The analyzer is supplied with a removable flowcell to allow for use of 1 cm square as well as 12 mm round cuvettes. The analyzer is designed with many features to minimize operator error, such as stable factory calibration, pre-programmed calculations, visual and audible feedback, flags and error messages. In addition, it will store up to 512 patient results, 512 control results, 20 patients on a work list and 15 tests per patient. * Not available for clinical human blood testing in the United States Specifications Specifications Spectrophotometer Type: Filter Channels: 120 open Optical Configuration: Single beam with continuously rotating filter wheel. Monochromatic or bichromatic reading 8 filter positions. Source of Radiation: Tungsten Halogen, 10 watt, with automatic lamp saver. Usable Spectral Range: 330 to 770 nm Selection if Wavelength: By Filter. System Procedures: Calculating Modes: Open and Stored Menu. Absorbance Single Standard Differential Samples Factor Mode Differential Samples Multi-Standard Mode (up to 7 standards) Differential Samples Multi-Standard % ABS (up to 7 standards) Differential Samples Kinetic Mode (Consecutively, or Simultaneously (Batch)) By Factor or Standard Fixed Time Kinetic By Factor or Standard Filter Type: Wavelength Accuracy: 4-cavity interference, long-life ion beam-assisted deposition. ± 3 nm Filter Location: After sample (heat absorbing filter before sample). Filter Selection: Wavelengths: Half Bandwidth: Automatic by software or via keyboard. 340, 405, 505, 545, 580, 630 nm supplied standard, others optional. N/A 1/100 bandwidth: 14 nm at 340 nm. False Radiant Energy Ratio: <0.001 at 340 and 405 nm. Cuvette: Type Supplied: 1 cm square, 12 mm round, flow through. Flow through. Index Mode Material: 316 stainless, borosilicate windows. 08

9 Analyzers Pointe 180 II (continued) Catalog: 90.P Geometry: Cylindrical, 2.3 mm dia x 5 mm +/ mm. Illuminated Volume: 21 ul Minimum Read Volume: 250 ul Aspiration / Purge: Vacuum pump at 18 cm of Hg. Valve: Silicone pinch type Cuvette Holder: Thermostatically controlled compartment at 37 C. Detector: Gallium-Arsenide-Phosphide photodiode. Power: Fuses: Dimensions and Weight: Auto-Switching Power supply. Voltage source: VAC Frequency: 50/60 Hz Power consumption: 60 watts Installation Category: CAT II 2.5A/250V fast 5-20 mm glass fuse 2.0A/250V Fast 5-20 mm Ceramic Fuse (2) 6/10 250V slow blow 3AG Fuses 40 cm (L) x 37 cm (W) x 14 cm (H) lid closed (30 cm lid opened), 6.4 kg Display Type: 240x128 graphic LCD w/backlight Space Requirements: 10 cm clearance on all sides. Absorbance: -0.5 to 3.5 (flow through mode) -0.5 to 2.5 (tube or 1 cm cuvette) Concentration: Maximum 999,999 Kinetic Results: Zero Compensation: Range: Parallel: Serial: Abs/min with resolution of A/min Automatic -0.5 to 2.5 absorbance Centronics/IBM-PC compatible RS-232 at 9600 baud, 8 data, 1 stop, no parity Bi-directional. Environmental Conditions for Safe Operation: Indoor Use Altitude up to 2000m. Temperature 5 C to 40 C (Although it may be safe to operate in these conditions, it may be suitable for the performance of the user s tests. Humidity 85% for temperatures up to 30 C decreasing linearity to 50% humidity at 40 C. Main supply voltage fluctuations not to exceed +/- 10% of nominal voltage. Recommended Operating Temperature: C Recommended Operating Between 10 and 85%, Humidity: non-condensing Data Input: 1) 20 key keypad 2) PS2 101 keyboard (connector on back) Spectrophotometric Inaccuracy Flow Through: Stability: <0.5 % at 1 absorbance, 340/630 nm NADH Solution. <1.0 % at 2 absorbance, 340/630 nm NADH Solution. <3.0 % at 3 absorbance, 340/630 nm NADH Solution. <0.5 % at 1 absorbance, 405/630 nm PNP Solution. <1.0 % at 2 absorbance, 405/630 nm PNP Solution. <3.0 % at 3 absorbance, 405/630 nm PNP Solution. Better than A/hr monochromatic after warmup. Warmup Time: 90 seconds photometric, 15 minutes for temperature compartment. Electronics: Z180 Microprocessor 18 MHz, 128k EPROM, 32 K Bytes NVRAM. 09

10 Analyzers Pointe 180 QT * (Quick Touch) Catalog: 90.P4504-QT A compact, microprocessor controlled analyzer that can read and calculate results of endpoint, kinetic, initial rate and colorimetric assays. The streamlined design offers touch screen interface, superb optics, a 37 C on-board heating block with 12 wells and a built-in printer. Pointe Scientific has combined a high degree of ergonomics and quality of results, into one compact system. It is a lightweight, economical, standalone analyzer. Along with its streamlined design and interactive touch-screen LCD interface, it features superb optics, on-board curve-fitting software and a built-in printer to meet the requirements of today s modern laboratories. * Not available for clinical human blood testing in the United States Specifications Specifications Linear Measurement Range: Tube or cuvette to 3.0A Interface: USB mouse, USB 2.0 compatible Photometric Accuracy: +/- 1% of the reading A Stability: Drift of no more than 0.005A in 8 hours/bichromatic Light Source: Tungsten lamp with lamp-saver feature Standard 340, 405, 505, 545, 580 and 630 nm Wavelengths: Alternate filters available from 340 to 700 nm Filter Type: IAD hardcoat interference, 10 nm half bandpass Tube 12 mm round is standard Minimum Reaction Volume: 1 ml for 12 mm round tube Display: Interactive touch screen 3.5 LCD color graphic display Speed: Reads, calculates and prints results - 3 seconds per tube Calculation Modes: All modes kinetically Absorbance Factor Standard Point-to-Point Regression Cubic Spline Test Menu: More than 50 open channels to store tests. Stores all parameters including wavelengths, calculations, unit codes, linear and normal ranges, rate timing, standard values, test names, and previous standard curve. Temperature Control: Read cell and incubation block, user selectable Printer: Thermal dot matrix with graphic capability Enclosure: Flame-retardant ABS plastic cover and base Power Requirements: Microprocessor: 115V or 230V AC, 1.5A, 50-60Hz (universal input) ez80, 64K EEPROM Dimensions: Weight: Approximately 9 x 13.5 x 5 in (24 x 34 x 13 cm) 10 lbs (4.5 kg) Memory: 768K bytes Flash Memory, 512K static RAM memory 10

11 Pointe 180 Impulse * Catalog: 90.P Analyzers The Pointe 180 impulse is an ISE Electrolyte Analyzer specifically designed for the direct determination of Na+, K+ and Cl- by ion selective electrodes in whole blood, serum, and aqueous QC material. Reagent packs, electrodes, and the instrument itself all contain unique electronics allowing for self calibration and monitoring for troubleshooting. The analyzer is a bottle-free, stand alone, bench top, ISE electrolyte analyzer designed for the direct determination of Na+, K+ and Cl- by ion selective electrodes. The unit contains a built in thermal dot matrix printer. The unit is programmable through custom software allowing the user to define programs following their own established protocols. The software is displayed on an interactive touch screen which guides the user step-by-step through the process using screen prompts, error messages and graphical displays. Reagents are supplied in packs which plug into the side of the unit with no user contact to waste material. The unit will track reagent expiration and quantity of reagent remaining. * Not available for clinical human blood testing in the United States Specifications Specifications Method: Sample Type: Sample 60µl ± 5µl Sample Rate: Direct measurement by ion selective electrode Whole Blood, Serum, Aqueous QC Material 48/hour maximum without printing 45/hour maximum with printing Measurement Sodium mmol/l Ranges: Potassium mmol/l Chloride mmol/l Sample Probe: Vessels: Electrodes: 316 Stainless Steel Capillary tubes with adaptor, tubes up to 100 mm depth, syringes, sample cups Sodium (Na+) Electrode Potassium (K+) Electrode Chloride (Cl-) Electrode Patient Data 200 results (with capability to assign a 15 Storage: character patient identifier) QC Data Storage: Calibration: 270 readings (30 readings each of 3 controls for each of the 3 electrodes, includes Levey-Jennings) On demand or automatic from 1 to 8 hour intervals Power Requirements: VAC, 50-60Hz 90W maximum Dimensions: 14 w x 12 h x 8 d (35.5 cm x 30.5 cm x 20 cm) Weight (with reagent pack): 14.5 lbs (6.6 kg) Display: Interface: Interactive touch screen 3.5 (9cm) LCD color graphic display Indirect via USB Drive (Included) Printer: Thermal dot matrix with graphic capability, 29 character width Analysis Time: Typically < 60 seconds 11

12 Analyzers Pointe c2000 Catalog: C2000 The Pointe c2000 Chemistry Analyzer is a benchtop analyzer offering a perfect solution for small and medium volume international laboratories. The analyzer can be ordered with or without the electrolyte (ISE) module. A large chemistry test menu is comprised of Pointe Scientific s barcoded and packaged reagents that are manufactured specifically for this analyzer. The Pointe c2000 analyzer provides key features that are commonly found on larger systems. These features provide a simple and smooth operational environment for the laboratory. There are minimal daily startup procedures; dual power switches allowing reagents to be permanently stored in the on-board refrigerated compartment; a probe management system offering liquid-level sensing and collision protection and a reagent management system that keeps track of reagent usage and alerts the operator when additional reagent is needed. Specifications Specifications This analyzer s proven track record in operation and reliability allows it to only need one preventive maintenance visit per year. System Function Throughput: Measuring Principles: System Procedures: Methodology: Automatic, Discrete, Random Access STAT Sample Priority Up to 200 tests/hour Absorbance Photometry, Turbidimetry Open and Stored Menu. End-point, Fixed-time, Kinetic Single/Dual Reagent Chemistries Monochromatic / Bichromatic Automatic Sample Dilution: Pre-dilution and post-dilution ratio up to 1:150 Dilution Vessel: Disposable cuvette; Maximum 80 positions Internal Barcode Reader Sample and reagent barcode scan Applicable to various barcode systems: Codabar, ITF (Interleaved Two of Five), code128, code39, UPC/EAN, Code93 Programming: Linear / non-linear multi-point calibration Open system, user-defined profiles and chemistry calculations Reaction Rotor: Cuvette: Rotating Tray (80 cuvettes) Optical length 5mm Reagent/Sample Tray: 40 positions for reagents and 40 positions for samples in refrigerated compartment (4~15 C) Reagent Volume R1: 180~450 µl, step by 1 µl R2: ~450 µl, step by 1 µl Sample Volume: 3~45 µl, step by 0.5 µl Probe Cleaning: Liquid Level Detection Horizontal and Vertical Collision Protection Inventory Detection Automatic interior and exterior probe wash Carry-over < 0.1% Reaction Volume: Operating Temperature: 180~500 μl 37 C Temperature Fluctuation: ± 0.1 C Mixing System: Light Source: Photometer: Standalone mixing bar Halogen-Tungsten Lamp Reversed optics, Static fiber spot photometry 12

13 Analyzers Pointe c2000 (continued) Catalog: C2000 Wavelength: Absorbance Range: Resolution: Calibration Mode: Control Software: Operating System: Interface: Power Supply: 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm 0~4.0 Abs (10mm conversion) Abs Linear (one-point, two-point and multipoint) Logit-Log 4P, Logit-Log 5P, Spline, Exponential 5P, Polynomial 5P, Parabola, K-Factor Westgard Multi-Rule, Cumulative Sum Check, Twin Plot; L-J Windows XP Professional/Home SP2 or above Windows VISTA Home/Business Windows 7 Professional 32 bit RS-232 AC100~130V or AC200~240V, 50/60Hz, 1000W Temperature: 15 C ~ 30 C Humidity: 35~80 % Water Consumption: Dimensions: Benchtop Benchtop With Cabinet 3.5 Liters Per Hour Weight: Benchtop lbs kg Cabinet (Optional) lbs kg - 51 in - 34 (W) x 28 (D) x 25 (H) cm - 86 (W) x 71 (D) x 64 (H) in - 34 (W) x 28 (D) x 46 (H) cm - 86 (W) x 71 (D) x 117 (H) 13

14 Instrument Specific Instrument Specific Beckman Coulter AU Hitachi Mindray BS

15 Instrument Specific Beckman Coulter AU 400, 480, 640 Packaged and Barcoded Reagents Catalog # OA OA OA OA OA OB OB OB OC OC OC OC OC OG OG OH OH OI OL OL OM Product Albumin Alkaline Phosphatase ALT Amylase AST Bilirubin - Direct Bilirubin - Total BUN (Urea Nitrogen) Calcium Carbon Dioxide Cholesterol Creatine Kinase Creatinine γ-glutamyl Transferase Glucose Hexokinase autohdl Cholesterol Hemoglobin A1c Iron - Total Lactate Dehydrogenase autoldl Cholesterol Magnesium Configuration 12 x 66 ml 5 x 50 ml/4 x 13 ml 6 x 67 ml/5 x 17 ml 6 x 63 ml/5 x 17 ml 6 x 67 ml/5 x 17 ml 5 x 18 ml/4 x 6 ml 9 x 63 ml/9 x 16 ml 6 x 66 ml/2 x 43 ml 6 x 66 ml/6 x 30 ml 4 x 45ml 12 x 65 ml 4 x 60 ml/4 x 15 ml 9 x 67 ml/8 x 17 ml 5 x 42 ml/5 x 17 ml 6 x 66 ml 6 x 60 ml/6 x 20 ml 2 x 15ml/1 x 10 ml 6 x 66 ml/5 x 17 ml 5 x 42 ml/5 x 17 ml 6 x 60 ml/6 x 20 ml 6 x 25 ml/6 x 25 ml 15

16 Beckman Coulter AU 400, 480, 640 (continued) Instrument Specific Packaged and Barcoded Reagents Catalog # OP OT OT OU Product Phosphorus Protein - Total Triglycerides Uric Acid Configuration 6 x 66 ml/6 x 30 ml 6 x 66 ml/6 x 30 ml 12 x 65 ml 9 x 65 ml/8 x 16 ml 16

17 Hitachi 717, 911, 912, 914 Catalog # HA HA HA HA HA HA HB HB HB HC HC HC HI790-CEW HC HC HC C C HI790-DET HI990-DET HG G HG HH Product Acid Phosphatase* Albumin Alkaline Phosphatase ALT Amylase AST Bilirubin - Direct Bilirubin - Total BUN (Urea Nitrogen) Calcium Carbon Dioxide* Carbon Dioxide* Cell Wash Cholesterol Creatine Kinase Creatinine CRP* CRP* Detergent Detergent γ-glutamyl Transferase Glucose Hexokinase* Glucose Oxidase autohdl Cholesterol Instrument Specific Packaged and Barcoded Reagents * Non-Barcoded User Defined Assay Configuration 6 x 10 ml 14 x 100 ml 4 x 100 ml/4 x 23 ml 5 x 100 ml/2 x 50 ml 12 x 22 ml/6 x 10 ml 5 x 100 ml/2 x 50 ml 12 x 19 ml/6 x 11 ml 6 x 90 ml/3 x 51 ml 8 x 100 ml/4 x 50 ml 7 x 100 ml/3 x 100 ml 10 x 20 ml 8 x 50 ml 6 x 2 L 10 x 100 ml 2 x 100 ml/2 x 25 ml 11 x 100 ml/3 x 80 ml 1 x 50 ml / 1 x 50 ml 1 x 20 ml / 1 x 20 ml 1 x 1 L 14 x 100 ml 5 x 45 ml/2 x 45 ml 1 x 120 ml 10 x 100 ml 6 x 30 ml/3 x 20 ml 17

18 Instrument Specific Hitachi Packaged and Barcoded Reagents 717, 911, 912, 914 (continued) * Non-Barcoded User Defined Assay Catalog # H H H HI HI790-KCL HI990-KCL HI790-DIL HI990-DIL HI790-REF HI990-REF HI790-STH HI790-STL HL L Product autohdl Cholesterol* autohdl Cholesterol* Hemoglobin A1c Iron - Total ISE 1N KCL Solution ISE 1N KCL Solution ISE Diluent ISE Diluent ISE Internal Reference ISE Internal Reference ISE Standard - High ISE Standard - Low Lactate Dehydrogenase Lactate* Configuration 1 x 60 ml/1 x 20 ml 1 x 30 ml/1 x 10 ml 1 x 30ml/1 x 10ml/ Lyse 1 x 125ml 5 x 100 ml/1 x 100 ml 1 x 1 L 5 x 300 ml 6 x 2 L 5 x 300 ml 6 x 2 L 5 x 600 ml 10 x 2 ml 10 x 2 ml 4 x 100 ml/8 x 21 ml 1 x 30 ml/1 x 20 ml 18

19 Hitachi 717, 911, 912, 914 (continued) Instrument Specific Packaged and Barcoded Reagents * Non-Barcoded User Defined Assay Catalog # L L HM M HP HP HP HT HI790-SCS HI HT HU Product autoldl Cholesterol* autoldl Cholesterol* Magnesium Microalbumin* Microprotein* Microprotein* Phosphorus Protein - Total System Cleaning Solution TIBC - Direct* Triglycerides Uric Acid Configuration 1 x 60 ml/1 x 20 ml 1 x 30 ml/1 x 10 ml 4 x 50 ml/4 x 50 ml 4 x 20 ml/2 x 10 ml 8 x 50 ml/1 x 15 ml 4 x 50 ml/1 x 15 ml 8 x 100 ml/4 x 100 ml 8 x 100 ml/4 x 100 ml 1 x 500 ml 1 x 90 ml/1 x 30 ml 10 x 100 ml 5 x 100 ml/5 x 23 ml 19

20 Instrument Specific Hitachi Packaged and Barcoded Reagents 917 * Non-Barcoded User Defined Assay Catalog # HA HA HA HA HA HA HB HB HB HB HC HC HI790-CEW HC HC HC HD HG G HG HH H HI HI790-KCL Product Acid Wash Albumin Alkaline Phosphatase ALT Amylase AST Base Wash Bilirubin - Direct Bilirubin - Total BUN (Urea Nitrogen) Calcium Carbon Dioxide* Cell Wash Cholesterol Creatine Kinase Creatinine Detergent γ-glutamyl Transferase Glucose Hexokinase* Glucose Oxidase autohdl Cholesterol Hemoglobin A1c Iron - Total ISE 1N KCL Solution Configuration 12 x 67 ml 12 x 66 ml 5 x 50 ml/4 x 13 ml 6 x 67 ml/6 x 17 ml 6 x 63 ml/6 x 17 ml 6 x 67 ml/6 x 17 ml 12 x 67 ml 5 x 18 ml/5 x 6 ml 9 x 63 ml/9 x 16 ml 6 x 66 ml/6 x 43 ml 6 x 66 ml/6 x 30 ml 4 x 45 ml 6 x 2 L 12 x 65 ml 4 x 60 ml/4 x 15 ml 9 x 67 ml/9 x 17 ml 12 x 70 ml 5 x 42 ml/5 x 17 ml 1 x 120 ml 12 x 67 ml 6 x 60 ml/6 x 20 ml 1 x 90ml/1 x 30ml 6 x 66 ml/6 x 17 ml 1 x 1 L 20

21 Hitachi 917 (continued) Catalog # HI790-DIL HI790-REF HI790-STH HI790-STL HL HL HM HP HT HI HT HU Product ISE Diluent ISE Internal Reference ISE Standard - High ISE Standard - Low Lactate Dehydrogenase autoldl Cholesterol Magnesium Phosphorus Protein - Total TIBC - Direct* Triglycerides Uric Acid Instrument Specific Packaged and Barcoded Reagents * Non-Barcoded User Defined Assay Configuration 6 x 2 L 6 x 2 L 10 x 2 ml 10 x 2 ml 5 x 42 ml/5 x 17 ml 6 x 60 ml/6 x 20 ml 6 x 25 ml/6 x 25 ml 6 x 66 ml/6 x 30 ml 6 x 66 ml/6 x 30 ml 1 x 60 ml/1 x 20 ml 12 x 65 ml 9 x 65 ml/9 x 16 ml HL HL HL HL HL User Defined Bar Code Label User Defined Bar Code Label User Defined Bar Code Label User Defined Bar Code Label User Defined Bar Code Label Labels 60 Labels 60 Labels 60 Labels 60 Labels 21

22 Instrument Specific Mindray BS-200 Packaged and Barcoded Reagents * Non-Barcoded User Defined Assay Catalog # 12-A A A A A HB HB B C C C C C C F G G H H HI L L L HM Product Albumin Alkaline Phosphatase ALT Amylase AST Bilirubin - Direct Bilirubin - Total BUN (Urea Nitrogen) Calcium Carbon Dioxide Cholesterol Creatine Kinase Creatinine CRP Fructosamine γ-glutamyl Transferase Glucose Hexokinase* autohdl Cholesterol Hemoglobin A1c Iron - Total Lactate Dehydrogenase autoldl Cholesterol Lipase Magnesium Configuration 4 x 40 ml 2 x 40 ml/2 x 10 ml 2 x 40 ml/2 x 10 ml 3 x 40 ml 2 x 40 ml/2 x 10 ml 3 x 40 ml/3 x 12 ml 4 x 40 ml/4 x 8 ml 3 x 40 ml/3 x 10 ml 3 x 40 ml 4 x 40 ml 4 x 40 ml 2 x 40 ml/2 x 10 ml 2 x 40 ml/2 x 9 ml 1 x 20 ml/1 x 20 ml 5 x 11 ml 2 x 40 ml/2 x 10 ml 1 x 120 ml 3 x 40 ml/3 x 14 ml 1 x 30ml/1 x 10ml/ Lyse 1 x 125ml 3 x 40 ml/3 x 8 ml 2 x 40 ml/2 x 10 ml 3 x 40 ml/3 x 14 ml 4 x 10 ml/1 x 14 ml 2 x 40 ml/2 x 40 ml 22

23 Mindray BS-200 (continued) Catalog # 12-P T T U BS200-SCS Product Phosphorus Protein - Total Triglycerides Uric Acid Wash Solution Instrument Specific Packaged and Barcoded Reagents * Non-Barcoded User Defined Assay Configuration 4 x 40 ml 3 x 40 ml 4 x 40 ml 3 x 40 ml 9 x 40 ml 23

24 Diagnostic Reagents Diagnostic Reagents Chemistry Reagents Large Volume Packaging

25 Chemistry Reagents Acid Phosphatase Catalog: A7503 Diagnostic Reagents Alcohol Catalog: A7504 Method: α-naphthylphosphate, Kinetic Format: Dry Powder Wavelength: 405 nm Linearity: 40 U/L Expected Values: Total Acid Phosphatase: U/L Prostatic Acid Phosphatase: U/L Reconstituted Stability: 24 hrs at RT,14 days at 2-8 C A Reagent 10 x 10 ml L-Tartrate 1 x 5 ml Acetate Buffer 1 x 15 ml Chemistry Control (Levels 1 & 2) C Method: Alcohol Dehydrogenase, Endpoint Format: Dry Powder Wavelength: 340 nm Linearity: 0.4 g/dl Expected Values: <0.1g/dL Reconstituted Stability: 7 days at 2-8 C A x 6.5 ml A x 15 ml Alcohol Standard A7504-STD Ammonia/Alcohol Control Set A7504-CTL Albumin Catalog: A7502 Method: Bromcresol Green, Endpoint Wavelength: 630 nm Linearity: g/dl Expected Values: g/dl Storage Temperature: RT A x 120 ml A x 500 ml A7502-1L 1 x 1L Albumin Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) A7502-STD C C Alkaline Phosphatase Catalog: A7516 Method: p-npp, Kinetic Wavelength: 405 nm Linearity: U/L Expected Values: Adults U/L, Children have a higher normal value A x 120 ml R1, 1 x 30 ml R2 A x 120 ml R1, 1 x 90 ml R2 A x 500 ml R1, 1 x 125 ml R2 Chemistry Control (Levels 1 & 2) C

26 Diagnostic Reagents Chemistry Reagents ALT Catalog: A7526 Method: Modified IFCC, Kinetic Wavelength: 340 nm Linearity: U/L Expected Values: 4-36 U/L A x 120 ml R1 1 x 30 ml R2 A x 120 ml R1 1 x 90 ml R2 A x 500 ml R1 1 x 125 ml R2 Chemistry Control (Levels 1 & 2) C Amylase Catalog: A7564 Method: CNPG3, Kinetic Wavelength: 405 nm Linearity: 0-2,000 U/L Expected Values: U/L A x 30 ml A x 30 ml A x 120 ml A7564-1L 1 x 1 L Chemistry Control (Levels 1 & 2) C Ammonia Catalog: A7553 Method: α-ketoglutarate, endpoint Format: Dry Powder Wavelength: 340 nm Linearity: 600 umol/l Expected Values: umol/l Reconstituted Stability: 15 days at 2-8 C A x 6.5 ml Substrate 4 x 2 ml Enzyme A x 6.5 ml Substrate 10 x 2 ml Enzyme Ammonia 100 Standard Ammonia 500 Standard Ammonia/Alcohol Control Set AST Catalog: A7561 Method: Modified IFCC, Kinetic Technical Information Wavelength: 340 nm Linearity: U/L Expected Values: 5-34 U/L A7553- STD100 A7553-STD500 A7504-CTL A x 120 ml R1 1 x 30 ml R2 A x 120 ml R1 1 x 90 ml R2 A x 500 ml R1 1 x 125 ml R2 Chemistry Control (Levels 1 & 2) C

27 Chemistry Reagents Bilirubin - Direct Catalog: B7538 Method: Diazo, Endpoint Wavelength: 550 nm Linearity: 20 mg/dl Expected Values: mg/dl Storage Temperature: RT B x 120 ml Reagent 1 x 15 ml Nitrite B x 500 ml Reagent 1 x 15 ml Nitrite B7538-1L 1 x 1 L Reagent 1 x 15 ml Nitrite Bilirubin Calibrator Set Chemistry Calibrator Chemistry Control (Levels 1 & 2) B7538-CAL C C Diagnostic Reagents Bilirubin - Total Catalog: B7576 Method: Walters & Gerarde, Endpoint Wavelength: 550 nm Linearity: 20 mg/dl Expected Values: mg/dl B x 120 ml Reagent 1 x 15 ml Nitrite B x 500 ml Reagent 1 x 15 ml Nitrite B7576-1L 1 x 1 L Reagent 1 x 15 ml Nitrite Bilirubin Calibrator Set Chemistry Calibrator Chemistry Control (Levels 1 & 2) B7538-CAL C C BUN (Urea Nitrogen) - Colormetric Catalog: B7551 Method: Berthelot, Endpoint Wavelength: 630 nm Linearity: 45 mg/dl Expected Values: 7-18 mg/dl B x 60 ml Enzyme 1 x 60 ml Color 1 x 240 ml Base 1 x 4 ml Standard Chemistry Control (Levels 1 & 2) C

28 Diagnostic Reagents Chemistry Reagents BUN (Urea Nitrogen) Catalog: B7552 Method: Urease/GLDH, Initial Rate Wavelength: 340 nm Linearity: mg/dl Expected Values: 7-18 mg/dl B x 120 ml R1 1 x 30 ml R2 B x 120 ml R1 1 x 90 ml R2 B x 500 ml R1 1 x 125 ml R2 BUN (Urea Nitrogen) Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) B7550-STD C C Calcium Catalog: C7503 Method: Cresolphthalein Complexone, Endpoint Wavelength: 570 nm Linearity: 20 mg/dl Expected Values: mg/dl C x 30 ml Color 2 x 30 ml Buffer C x 120 ml Color 2 x 120 ml Buffer Calcium Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) C7503-STD C C Calcium (Arsenazo) Catalog: C7529 Method: Arsenazo III, Endpoint Wavelength: 650 nm Linearity: 0-15 mg/dl Expected Values: mg/dl Storage Temperature: RT C x 120 ml C x 500 ml C7529-1L 1 x 1 L Calcium Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) C7503-STD C C

29 Diagnostic Reagents Chemistry Reagents Carbon Dioxide Catalog: C7502 Method: Enzymatic, PEPC and NADH Analog Wavelength: 405 nm Linearity: 2-40 mmol/l Expected Values: mmol/l C x 120 ml C x 120 ml C7502-1L 1 x 1 L Carbon Dioxide Standard Chemistry Calibrator Chemistry Control (Levels 1 and 2) C7504-STD C C Cholesterol Catalog: C7510 Method: Enzymatic, Endpoint Wavelength: 500 nm Linearity: 700 mg/dl Expected Values: Desirable Cholesterol: <200 mg/dl Borderline-High Cholesterol: mg/dl High Cholesterol: >240 mg/dl C x 120 ml C x 500 ml C7510-1L 1 x 1 L Cholesterol Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) Lipid Control Set (Levels 1 & 2) C7509-STD C C L CK-MB Catalog: C7562 Method: Immunoinhibition, Kinetic Format: Dry Powder Wavelength: 340 nm Linearity: 175 U/L Expected Values: 0-24 U/L Reconstituted Stability: 5 days at 2-8 C C x 6.5 ml C x 6.5 ml C x 15 ml CK-MB Control Set C

30 Diagnostic Reagents Chemistry Reagents Creatinine Catalog: C7539 Method: Modified Jaffe, Initial Rate Wavelength: 510 nm Linearity: 25 mg/dl Expected Values: mg/dl Storage Temperature: RT C x 120 ml R1 1 x 30 ml R2 C x 500 ml R1 1 x 125 ml R2 C x 1 L R1 1 x 250 ml R2 Creatinine Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) Creatine Kinase Catalog: C7522 Method: CK-NAC, Kinetic C7513-STD C C Wavelength: 340 nm Linearity: 1-1,200 U/L Expected Values: Males: U/L, Females: U/L C x 120 ml R1 1 x 30 ml R2 C x 120 ml R1 1 x 90 ml R2 C x 500 ml R1 1 x 125 ml R2 Chemistry Control (Levels 1 & 2) C Creatinine Enzymatic Catalog: C7548 Method: Enzymatic Wavelength: 550 nm Linearity: 30 mg/dl Expected Values: Male (serum): mg/dl, Female (serum): mg/dl, Male (urine): mg/24hrs, Female (urine): mg/24hrs Storage Temperature: 2-8 C C x 90 ml R1 1 x 30 ml R2 C x 120 ml R1 1 x 120 ml R2 C L 1 x 750 ml R1 1 x 250 ml R2 Chemistry Calibrator C Chemistry Control (Levels 1 & 2) C Creatinine Standard C7513-STD Urine Control Set P7582-CTL 30

31 Diagnostic Reagents Chemistry Reagents CRP Catalog: C7568 Fructosamine Catalog: F7546 Method: Immunoturbidimetric Wavelength: 570 nm Linearity: mg/dl Expected Values: <3.0 mg/dl C x 20 ml R1 Buffer 1 x 20 ml R2 Antibody C x 50 ml R1 Buffer 1 x 50 ml R2 Antibody Calibrator/Standard Required CRP Standard Set CRP Control Set CRP Calibrator Set G6PD Catalog: G7583 Method: Glucose-6-Phosphate, Kinetic C7568-STD C7568-CTL C7568-CAL Format: Dry Powder Wavelength: 340 nm Linearity: 21.0 U/g Hb Expected Values: 12.1±2.09 U/g Hb Reconstituted Stability: 8 hrs at RT, 5 days at 2-8 C G x 6 ml R1 1 x 120 ml R2 G6PD Control Set G6PD Lyse Reagent G7583-CTL G7583-LYS Method: Nitroblue Tetrazolium Format: Dry Powder Wavelength: 550 nm Linearity: mmol/l Expected Values: mmol/l Reconstituted Stability: 7 days RT, 30 days 2-8 C F x 11 ml Substrate 1 x 120 ml Buffer 1 x 2 ml Calibrator Fructosamine Calibrator Fructosamine Control Set F7546-CAL F7546-CTL Glucose Hexokinase Catalog: G7517 Method: Hexokinase/G6PD, Endpoint Wavelength: 340 nm Linearity: 600 mg/dl Expected Values: mg/dl G x 120 ml G x 500 ml G7517-1L 1 x 1 L Calibrator/Standard Required Glucose Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) G7518-STD C C

32 Diagnostic Reagents Chemistry Reagents Glucose Oxidase Catalog: G7521 Glycohemoglobin Catalog: G7540 Method: Oxidase/Trinder, Endpoint Wavelength: 500 nm Linearity: 500 mg/dl Expected Values: mg/dl G x 120 ml G x 500 ml G7521-1L 1 x 1 L Glucose Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) G7518-STD C C γ-glutamyl Transferase Catalog: G7571 Method: Cation-Exchange Resin Wavelength: 415 nm Linearity: % Expected Values: % Storage Temperature: RT G x 120 ml Resin (40 Test) 1 x 30 ml Lysing 40 Serum Separators G x 120 ml Resin (80 Test) 1 x 30 ml Lysing 80 Serum Separators Standard Required Glycohemoglobin Control Set Glycohemoglobin Standard G G7540-STD Method: Modified Szasz, Kinetic Wavelength: 405 nm Linearity: U/L Expected Values: Male: 9-54 U/L Female: 8-35 U/L G x 120 ml R1 1 x 30 ml R2 G x 120 ml R1 1 x 90 ml R2 G x 500 ml R1 1 x 125 ml R2 Chemistry Control ( Levels 1 & 2 ) C

33 Diagnostic Reagents Chemistry Reagents autohdl Cholesterol Catalog: H7545 HDL Cholesterol - PEG Catalog: H7511 Method: Direct/Automated Wavelength: 600/700 nm Linearity: mg/dl Expected Values: mg/dl H x 30 ml R1 1 x 10 ml R2 H x 60 ml R1 1 x 20 ml R2 H x 240 ml R1 1 x 80 ml R2 H x 750 ml R1 1 x 250 ml R2 Calibrator Required Method: PEG (Polyethylene Glycol) Precipitating Reagent Wavelength: 500 nm Expected Values: mg/dl Storage Temperature: RT H x 30 ml Calibrator/Standard Required Cholesterol - Liquid Cholesterol - Powder Cholesterol HDL Standard Lipid Control Set (Levels 1 & 2) C7510 C7509 H7512-STD L autohdl / LDL Calibrator Chemistry Control (Levels 1 & 2) Lipid Control Set (Levels 1 & 2) H7545-CAL C L

34 Diagnostic Reagents Chemistry Reagents Hemoglobin Catalog: H7504 Method: Cyanmethemoglobin, Endpoint Wavelength: 540 nm Linearity: 20.0 g/dl Expected Values: Males: g/dl, Females: g/ dl, Children: g/dl, Newborns: g/dl Storage Temperature: RT H x 120 ml H x 500 ml Standard Required Hemoglobin A1c Catalog: H7546 Method: Immunoturbidmetric Linearity: % Expected Values: <6.0% non diabetic H x 30 ml R1 1 x 10 ml R2 1 x 125 ml Lyse Reagent H x 90 ml R1 1 x 30 ml R2 Calibrator Required Hemoglobin Control Set Hemoglobin Standard H H7506-STD Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Set HbA1c Lyse Reagent H7541-CAL H7541-CTL H7541-LYS Homocysteine Catalog: H7575 Method: Enzymatic, Rate Wavelength: 340/380 nm Linearity: 1-46 umol/l Expected Values: 5-15 umol/l H x 50 ml R1 1 x 7 ml R2 2 x 3 ml Calibrator Homocysteine Control Set H7575-CTL 34

35 Diagnostic Reagents Chemistry Reagents β-hydroxybutyrate Catalog: H7587 Method: β-hydroxybutyrate Dehydrogenase, Endpoint Wavelength: 505 nm Linearity: 4.5 mm Expected Values: 0.02 to 0.27 mm H x 50 ml R1 1 x 8 ml R2 1 x 3 ml Standard β-hydroxybutyrate Control Set β-hydroxybutyrate Standard H7587-CTL H7587-STD Iron - TIBC Catalog: I7504 Iron - Total Catalog: I7505 Method: Ferrozine, Endpoint Wavelength: 560 nm Linearity: 500 ug/dl Expected Values: ug/dl I x 120 ml Buffer 1 x 5 ml Color I x 500 ml Buffer 1 x 15 ml Color Calibrator/Standard Required Chemistry Calibrator Chemistry Control (Levels 1 & 2) Iron Standard TIBC - Direct C C I7505-STD I7517 Method: Ferrozine, Endpoint Wavelength: 560 nm Linearity: 500 ug/dl Expected Values: Iron - Total: ug/dl, TIBC: ug/ dl, Iron Saturation: 20-55% I x 75 ml Iron Buffer 1 x 120 ml UIBC Buffer 1 x 15 ml Iron Color 2 x 30 ml Iron Standard I x 1 L Iron Buffer 1 x 1 L UIBC Buffer 1 x 60 ml Iron Color 1 x 500 ml Iron Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) Iron Standard TIBC - Direct C C I7505-STD I

36 Diagnostic Reagents Chemistry Reagents Iron - UIBC Catalog: I7506 Method: Endpoint Wavelength: 560 nm Expected Values: ug/dl I x 500 ml Standard Required Iron - Total I7505 Iron Standard I7505-STD Chemistry Control (Levels 1 and 2) C Lactate Catalog: L7596 Method: Lactate Oxidase, Endpoint Wavelength: 546/700 nm Linearity: 0-15 mmol/l Expected Values: mmol/l L x 30 ml R1 1 x 20 ml R2 Standard Required Lactate Standard Chemistry Control (Levels 1 & 2) L7596-STD C Lactate Dehydrogenase Catalog: L7572 Method: Modified Wacker/Tris, Kinetic Wavelength: 340 nm Linearity: 1000 U/L Expected Values: Male: U/L Female: U/L L x 120 ml R1 1 x 30 ml R2 L x 120 ml R1 1 x 90 ml R2 L x 500 ml R1 1 x 125 ml R2 Chemistry Control (Levels 1 & 2) C

37 Diagnostic Reagents Chemistry Reagents autoldl Cholesterol Catalog: L7574 Method: Direct/Automated Wavelength: 546/660 nm Linearity: mg/dl Expected Values: <130 mg/dl L x 30 ml R1 1 x 10 ml R2 L x 60 ml R1 1 x 20 ml R2 L x 240 ml R1 1 x 80 ml R2 Lipoprotein (a) Catalog: L7597 Method: Immunoturbidimetric Wavelength: 700 nm Linearity: 2-80 mg/dl Expected Values: Less than 30 mg/dl L x 30 ml R1 1 x 10 ml R2 Calibrator Required Lipoprotein (a) Calibrator Set L7597-CAL autohdl/ldl Calibrator Lipid Control Set (Levels 1 & 2) H7545-CAL L Lipase Catalog: L7503 Method: Enzymatic/Colorimetric, Initial Rate Format: Dry Powder Wavelength: 550 nm Linearity: 600 U/L Expected Values: 0-62 U/L Reconstituted Stability: 4 days RT, 21 days 2-8 C L x 10 ml Substrate 2 x 21 ml Substrate Buffer 1 x 14 ml Activator 1 x 3 ml Standard L x 10 ml Substrate 1 x 105 ml Substrate Buffer 3 x 14 ml Activator 1 x 3 ml Standard Chemistry Control (Levels 1 & 2) Lipase Standard C L7503-STD 37

38 Diagnostic Reagents Chemistry Reagents Microalbumin Catalog: M7562 Method: Immunoturbidimetric Wavelength: 340/700 nm Linearity: mg/dl Expected Values: mg / 24 hours M x 20 ml Buffer 2 x 10 ml Antiserum Calibrator Required Magnesium Catalog: HM929 Microalbumin Calibrator Set Microalbumin Control Set M7562-CAL M7562-CTL Method: Xylidyl Blue, Endpoint Wavelength: 530 nm Linearity: 4.86 mg/dl Expected Values: mg/dl Storage Temperature: RT HM x 30 ml R1 2 x 30 ml R2 HM x 120 ml R1 2 x 120 ml R2 HM x 500 ml R1 1 x 500 ml R2 Calibrator/Standard Required Microprotein Catalog: P7582 Method: Pyragallol Red, Endpoint Wavelength: 600 nm Linearity: 250 mg/dl Expected Values: mg / 24 hours P x 120 ml Reagent 1 x 15 ml Standard Chemistry Calibrator Chemistry Control (Levels 1 & 2) Magnesium Standard C C M7527-STD Microprotein Standard Urine Control Set P7582-STD P7582-CTL 38

39 Diagnostic Reagents Chemistry Reagents Phosphorus Catalog: P7516 Method: Phosphomolybdate, Endpoint Wavelength: 340 nm Linearity: 12 mg/dl Expected Values: mg/dl P x 120 ml P x 500 ml P7516-1L 1 x 1 L Calibrator/Standard Required Chemistry Calibrator Phosphorus Standard Chemistry Control (Levels 1 & 2) TIBC - Direct Catalog: I7517 C P7516-STD C Protein - Total Catalog: T7528 Method: Biuret, Endpoint Wavelength: 540 nm Linearity: g/dl Expected Values: g/dl Storage Temperature: RT T x 120 ml T x 500 ml T7528-1L 1 x 1 L Calibrator/Standard Required Chemistry Calibrator Chemistry Control (Levels 1 & 2) Protein - Total Standard C C T7528-STD Method: Chromazurol B Wavelength: 660 nm Linearity: ug/dl Expected Values: ug/dl I x 90 ml R1 1 x 60 ml R2 Calibrator Required Iron - TIBC Chemistry Control (Levels 1 & 2) TIBC - Direct Calibrator Set I7504 C I7517-CAL 39

40 Diagnostic Reagents Chemistry Reagents Triglycerides - Liquid Catalog: T7532 Method: Enzymatic/GPO Trinder, Endpoint Wavelength: 500nm Linearity: 1000 mg/dl Expected Values: mg/dl T x 120 ml T x 500 ml T7532-1L 1 x 1 L Calibrator/Standard Required Chemistry Calibrator Chemistry Control (Levels 1 & 2) Lipid Control Set (Levels 1 & 2) Triglyceride Standard Uric Acid Catalog: U7581 Method: Uricase/Trinder, Endpoint C C L T7531-STD Triglycerides - Powder Catalog: T7531 Method: Enzymatic/GPO Trinder, Endpoint Format: Dry Powder Wavelength: 540 nm Linearity: 1000 mg/dl Expected Values: mg/dl Reconstituted Stability: 2 days RT, 30 days 2-8 C T x 15 ml T x 15 ml T x 15 ml T x 50 ml T7531-1L 4 x 250 ml Calibrator/Standard Required Chemistry Calibrator Chemistry Control (Levels 1 & 2) Lipid Control Set (Levels 1 & 2) Triglyceride Standard C C L T7531-STD Wavelength: 520 nm Linearity: 20 mg/dl Expected Values: mg/dl U x 120 ml U x 500 ml U7581-1L 1 x 1 L Calibrator/Standard Required Chemistry Calibrator Chemistry Control (Levels 1 & 2) Uric Acid Standard C C U7580-STD 40

41 Diagnostic Reagents Large Volume Packaging Catalog # HA HA HA HA HA HB HB HB HC HC HC HC HG G7517-1L HI HL HM HP HT HT HU Product Albumin Alkaline Phosphatase ALT Amylase AST Bilirubin - Direct Bilirubin - Total BUN (Urea Nitrogen) Calcium Cholesterol Creatine Kinase Creatinine y-glutamyl Transferase Glucose Hexokinase Iron - Total Lactate Dehydrogenase Magnesium Phosphorus Protein - Total Triglycerides Uric Acid Configuration 1 x 2 L 1 x 2 L / 1 x 400 ml 1 x 2 L / 1 x 500 ml 1 x 1 L / 1 x 200 ml 1 x 2 L / 1 x 500 ml 1 x 1 L / 1 x 250 ml 1 x 2 L / 1 x 500 ml 1 x 2 L / 1 x 500 ml 1 x 2 L / 1 x 1 L 1 x 2 L 1 x 1 L / 1 x 200 ml 1 x 2 L / 1 x 500ml 1 x 1 L / 1 x 400 ml 1 x 1 L 1 x 1 L / 1 x 200 ml 1 x 1 L / 1 x 400 ml 1 x 500 ml / 1 x 500 ml 1 x 2 L / 1 x 1 L 1 x 2 L / 1 x 1 L 1 x 2 L 1 x 1 L / 1 x 250 ml 41

42 Enzyme Immunoassays Enzyme Immunoassays (EIA) Fertility Tests Steroid Tests Thyroid Tests Other Analytes ToRCH Panel Tumor Markers

43 Enzyme Immunoassays (EIA) Fertility Tests Ordering Information Other Analytes Ordering Information Catalog # Product Catalog # Product F FSH P Ferritin F hcg P IgE F LH CM Myoglobin F Prolactin CM Troponin I Steroid Tests Ordering Information Thyroid Tests Ordering Information Catalog # Product Catalog # Product S Cortisol* T T3 - Free S Estradiol T T3 S Progesterone T T4 - Free* S Testosterone T T4 * For Research Use Only in the US T TSH T U-TSH * For Research Use Only in the US 43

44 Enzyme Immunoassays (EIA) ToRCH Panel Ordering Information Tumor Markers Ordering Information Catalog # Product Catalog # Product T CMV lgg TM AFP* T CMV IgM TM CA 125* T HSV IgG TM CA 15-3* T Rubella IgG TM CA 19-9* T Rubella IgM TM CEA* T Toxoplasma IgG TM PSA - Free* T Toxoplasma IgM TM PSA* * For Research Use Only in the US 44

45 Calibrators/Standards Calibrators/Standards Calibrators Standards

46 Calibrators Calibrators/Standards Catalog # Product Size Stability C Chemistry Calibrator 10 x 5 ml 7 days at 2-8 C Diluent 1 x 55 ml C7568-CAL CRP Calibrator Set 5 x 2 ml Ready to use liquid Concentration: 5, 20, 40, 160, 320 mg/l C7568-STD CRP Standard Set 5 x 2 ml Ready to use liquid Concentration: 2.5, 10, 20, 80, 160 mg/l F7546-CAL Fructosamine Calibrator 1 x 2 ml Ready to use liquid H7545-CAL autohdl/ldl Calibrator 1 x 3 ml 21 days at 2-8 C H7541-CAL Hemoglobin A1c Calibrator Set 4 x 0.5 ml 30 days at 2-8 C L7597-CAL Lipoprotein (a) Calibrator Set 5 x 1 ml 14 days at 2-8 C M7562-CAL Microalbumin Calibrator Set 6 x 1 ml Ready to use liquid I7517-CAL TIBC - Direct Calibrator Set 2 x 1 ml 10 days at 2-8 C 46

47 Calibrators/Standards Standards Catalog # Product Concentration Size A7502-STD Albumin Standard 4.0 g/dl 1 x 15 ml A7504-STD Alcohol Standard 100 mg/dl approx 1 x 5 ml A7553-STD100 Ammonia 100 Standard 100 umol/l 1 x 4 ml A7553-STD500 Ammonia 500 Standard 500 umol/l 1 x 4 ml B7550-STD BUN Standard 20 mg/dl 1 x 15 ml C7503-STD Calcium Standard 10.0 mg/dl 1 x 15 ml C7504-STD Carbon Dioxide Standard 30 mmol/l 1 x 15 ml C7501-STD Chloride Standard 100 meq/l 1 x 15 ml H7512-STD Cholesterol HDL Standard 50 mg/dl 1 x 15 ml C7509-STD Cholesterol Standard 200 mg/dl 1 x 15 ml C7513-STD Creatinine Standard 2.5 mg/dl 1 x 15 ml G7518-STD Glucose Standard 100 mg/dl 1 x 15 ml G7540-STD Glycohemoglobin Standard 10.0% approx 1 x 1 ml H7506-STD Hemoglobin Standard 12.0 g/dl approx 1 x 2 ml H7587-STD β-hydroxybutyrate Standard 1.0 mm 1 x 3 ml I7505-STD Iron Standard 500 ug/dl 1 x 30 ml L7596-STD Lactate Standard 5.0 mmol/l 1 x 15 ml L7503-STD Lipase Standard 250 U/L approx 1 x 3 ml M7527-STD Magnesium Standard 2.4 mg/dl 1 x 15 ml P7582-STD Microprotein Standard 50 mg/dl 1 x 15 ml P7516-STD Phosphorus Standard 5.0 mg/dl 1 x 15 ml T7528-STD Protein - Total Standard 8.0 g/dl 1 x 15 ml T7531-STD Triglyceride Standard 200 mg/dl 1 x 15 ml U7580-STD Uric Acid Standard 5.0 mg/dl 1 x 15 ml 47

48 Quality Control Quality Control General Chemistry Controls Specialty Controls Urine Chemistry Controls

49 Quality Control General Chemistry Controls Catalog # Product Size Stability C Chemistry Control (Level 1) 10 x 5 ml 7 days at 2-8 C C Chemistry Control (Level 2) 10 x 5 ml 7 days at 2-8 C C Chemistry Control (Levels 1 and 2) 20 x 5 ml 7 days at 2-8 C L Lipid Control Set (Levels 1 and 2) 6 x 3 ml 7 days at 2-8 C Specialty Controls Catalog # Product Size Stability A7504-CTL Ammonia/Alcohol Control Set 2 x 5 ml Ready to use liquid C CK-MB Control Set 4 x 3 ml 7 days at 2-8 C C7568-CTL CRP Control Set 6 x 3 ml Ready to use liquid F7546-CTL Fructosamine Control Set 6 x 2 ml Ready to use liquid G Glycohemoglobin Control Set 2 x 1 ml 24hrs RT 30 days at 2-8 C 90 days at -20 C H7541-CTL Hemoglobin A1c Control Set 4 x 0.5 ml 30 days at 2-8 C H7546-CTL Hemoglobin A1c Control Set 2 x 1.0 ml 30 days at 2-8 C H Hemoglobin Control Set 3 x 2 ml 90 days at 2-8 C H7575-CTL Homocysteine Control Set 6 x 1.5 ml Ready to use liquid H7587-CTL β-hydroxybutyrate Control Set 6 x 5 ml Ready to use liquid Urine Chemistry Controls Catalog # Product Size Stability M7562-CTL Microalbumin Control Set 6 x 7 ml Ready to use liquid P7582-CTL Urine Control Set 6 x 10 ml Ready to use liquid 49

50 Consumables Consumables Beckman Coulter General Laboratory Hitachi Pointe 180 Series

51 Consumables Beckman Coulter Catalog # 1-B543 Product Beckman CX Bottles Size n/a General Laboratory Catalog # 90-12B L Product 12 x 75mm test tubes Redi-Check Linearity Set Size 250/Pack 1 Kit 51

52 Consumables Hitachi Catalog # HB HB HB Product Hitachi Reagent Bottles (20 ml) Hitachi Reagent Bottles (50 ml) Hitachi Reagent Bottles (100 ml) Size 10 x 20 ml 10 x 50 ml 10 x 100 ml Pointe 180 Series Catalog # B B B B B B B P L MTP400 Product Pointe 180 QT Printer Paper 12 x 75mm test tubes Pointe 180 impulse Cl- Electrode Pointe 180 impulse K+ Electrode Pointe 180 impulse Na+ Electrode Pointe 180 impulse Reagent Pack Pointe 180 impulse Reference Electrode Pointe 180 impulse Tri-Level QC Kit Pointe 180 Printer Paper Redi-Check Linearity Set Pointe 180 II Printer Paper Size 1 Roll 250/Pack n/a n/a n/a Reagent Pack n/a 30 x 2 ml 1 Roll 1 Kit 5 Rolls 52

53 OEM/B2B Partnership OEM/B2B Partnership Program Bulk Products Contract Manufacturing Private Label

54 OEM Partnership Program Original Equipment Manufacturer (OEM) Services The MedTest OEM Partnership Program offers many different unique solutions including custom Bulk, Contract Manufacturing, and Private Label products and services. Strengthen Market Position Enter New Markets Faster Maximize Profitability Bulk Products Predictable and Lower Costs Competitive Positioning Dedicated OEM Support Need larger volumes than our off-the-shelf package sizes? MedTest offers products with the same reliable technical specifications as our off-the-shelf Pointe Scientific brand products, but in larger, more cost-effective sizes. As a certified ISO 13485:2003 company, compliant with cgmp requirements, and offering CE marked products, we are able to assist our OEM partners with a number of specialized bulk product needs. Contract Manufacturing MedTest offers a flexible contract manufacturing program, in addition to our extensive range of Pointe Scientific brand off-the-shelf products. This includes dispensing, capping, and labeling for a wide variety of containers, packaging, and kit assembly. We believe this provides our partners with the ultimate in flexibility. As a certified ISO 13485:2003 company, compliant with cgmp requirements, and offering CE marked products, we are able to assist our OEM partners with a number of specialized contract manufacturing needs. Private Label We are able to offer our customers a number of options for their OEM needs. One of them is the MedTest Private Label OEM Partnership Program. This program gives value-added distributors and instrument manufacturers access to our Pointe Scientific brand product lines, while maintaining their own brand identity. As a certified ISO 13485:2003 company, compliant with cgmp requirements, and offering CE marked products, we are able to assist our OEM partners with a number of specialized private label needs. For More Information (USA) (International) Fax: marketing@medtest.com 54

55 Index A Acid Phosphatase 25 Creatinine Enzymatic 30 Albumin 25 CRP 31 Alcohol Alkaline Phosphatase ALT E Enzyme Immunoassays (EIA) 42 Ammonia Amylase Analyzers F Fructosamine 31 AST B Beckman Coulter AU TM G G6PD Glucose Hexokinase Beckman CX TM Bottles 51 Glucose Oxidase 32 Bilirubin - Direct 27 Glycohemoglobin 32 Bilirubin - Total 27 γ-glutamyl Transferase 32 BUN (Urea Nitrogen) - Colormetric BUN (Urea Nitrogen) C Calcium (Arsenazo) H autohdl TM Cholesterol HDL Cholesterol - PEG Hemoglobin Calcium 28 Hemoglobin A1c 34 Calibrators/Standards 45 Hitachi TM 717, 911, 912, Carbon Dioxide 29 Hitachi TM Cholesterol 29 Hitachi TM Reagents Bottles 52 CK-MB 29 Homocysteine 34 Consumables 50 β-hydroxybutyrate 35 Creatinine 30 Creatine Kinase 30 55

56 I Iron - TIBC Iron - Total Iron - UIBC Q Quality Controls - General Chemistry Quality Controls - Specialty Quality Controls - Urine Chemistry L Lactate Lactate Dehydrogenase autoldl TM Cholesterol Large Volume Packaging Lipase Lipoprotein (a) T TIBC - Direct Triglycerides - Liquid Triglycerides - Powder U Uric Acid M Magnesium 38 Microalbumin 38 Microprotein 38 Mindray TM BS O OEM/B2B Partnership Program 54 P Phosphorus 39 Pointe Pointe 180 II 08 Pointe 180 Impulse TM 11 Pointe 180 QT (Quick Touch) 10 Pointe c Protein - Total 39 56

57 General Information Our contact numbers are: U.S.A Worldwide Fax Web Site Customer Support / Technical Service / Order-To-Ship Process Customer Order Communication: Fax: Fax orders are accepted at A confirmation will not be faxed unless requested. orders are accepted at orders@medtest.com MedTest is committed to ensuring that we communicate the status of your orders with you in a timely fashion. To that extent, MedTest Customer Service will send an communication to you at the following intervals: Order Confirmation: It is at this point the standard lead times (listed below) are applied to your order. Customer Approval: All information listed on the order confirmation must be approved by the customer to be true and accurate. Without written approval, your order will not be scheduled with the production department. Processing Time: After we receive written approval and your order is scheduled with the production department, you will be provided with an estimated completion date for your order. Order Completion: It is at this time your order is ready to ship. You will have the opportunity to provide or revise any shipping instructions, requests for C of A s, copies of invoices, etc. Order Shipment: Tracking number and/or any specific information needed will be provided. Shipping Lead Times: Finished Kits: Items readily available in stock are immediately available and will be shipped according to customer s shipping requirements. An Order of 25 finished kits or more will have a lead time of up to 8 weeks. Custom Bulk: Up to 12 weeks Unlabeled Vials: Up to 12 weeks Hemoglobin A1c Custom Bulk/Unlabeled Vials: Up to 6 weeks Minimum Order Quantity: Custom Bulk: 5 Liters Unlabeled Vials: 25 Vials No Minimums: All Hemoglobin A1c Products Product Dating: 12 month expiration dating from date of shipment. Standing Orders: In order to simplify the ordering of routine products, standing orders are encouraged. Please contact us at for more information. Technical Service MedTest s Pointe Scientific Technical Service staff is trained to handle your reagent and instrument questions as well as general clinical laboratory questions. Phone: During regular business hours. Fax: Inquiries are usually answered within 24 hours. Website: Price Changes Current prices of Pointe Scientific products are subject to change without notification from MedTest. Orders will be billed at the price in effect at the time of order placement. Return Policy techservice@medtest.com Inquiries are usually answered within 24 hours. The Technical Support page on the Pointe Scientific website contains a Technical Support Request Form as well as a Live Chat feature. The Documentation page on our website offers the latest Technical Bulletins, Package Inserts, and Safety Data Sheets. MedTest fully stands behind all its product brands. We guarantee that all unexpired products will perform according to their stated parameters. It is recommended that all orders are inspected at the time of delivery. MedTest cannot be responsible for products that are held beyond the expiration date or are not stored according to instructions In the rare case that one of our products is not performing to stated specifications, we will gladly replace the product at no charge. Any product received due to an error on the part of MedTest may be returned for immediate replacement or full credit. We cannot accept returns on products that have past their expiration dates, or have six months or less remaining on the listed expiration date. All Returns Require A Return Merchandise Authorization (RMA). If you would like to request an RMA number, please fill out the form located under our Return Policy on our website at You may also contact one of our technical support representatives at Upon receipt of your RMA request, applicable instructions will be provided to make sure you understand the process, timelines and any responsibilities that may be required of you. An RMA number will be issued to you once management approval is received. OEM/Custom/Bulk Products The MedTest team is equipped to produce private label or custom-designed products quickly, efficiently and economically. We can also supply certain bulk liquid reagents as ingredient packs to reduce shipment costs. These reagents can then be reconstituted to form a liquid stable reagent. Please contact our marketing department at marketing@medtest.com for more information. Toxicity And Hazards Safety Data Sheets (SDS) are available for all Pointe Scientific products. Please visit the Documentation page on our website, or contact 57 the Technical Support Department at

58 Customer Support Technical Service Corporate Headquarters Phone: Fax: (U.S. Only) (International) Phone: (U.S. Only) (International) 5449 Research Drive Canton, MI International Sales Phone: (U.S. Only) (International) Accounting Phone: x111 (U.S. Only) (International) Mailing Address P.O. Box Canton, MI CA-M /16