Title: Panbio Dengue Early ELISA Revision Date : Sep. 03, 2013

Transcription

1 Page No. : 1 / 6 I. Product / Company Identification Product Name & Synonyms: Panbio Dengue Early ELISA Chemical Family: In-Vitro diagnostics Manufacturer : Standard Diagnostics, Inc. Manufacturer's Address : 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea Catalogue Number: 01PE40 (96well/kit) Formula: Not applicable Tel.: Poison Control Center (Korea) : (Emergency Number) PanbioTS@alere.com Web-site: Kit Components Overview Product Product Description Pack Size Statement of Hazardous Nature Code PAN Wash Buffer 20X Concentrate 60 ml Irritant R36/38,R43 PAN TMB Chromogen 15 ml Irritant R36/37/38 PAN Stop Solution 15 ml Irritant R36/38 PAN Sample Diluent 3 2 x 22mL Irritant R36/38,R43 PAN Dengue Early ELISA Anti-NS1 15 ml Irritant R36/38,R43 HRP Conjugate PAN Dengue Early ELISA Positive Control 1.2 ml Harmful R22,R32,R43 PAN Dengue Early ELISA Calibrator 1.5 ml Harmful R22,R32,R43 PAN Dengue Early ELISA Negative Control 1.2 ml Harmful R22,R32,R43 Irritant Xi Harmful Xn PAN Dengue Early ELISA Anti-NS1 Coated Microwells 1 plate Not Considered Hazardous CONTEXT: This MSDS should be interpreted in the context PROFESSIONAL USE ONLY specifically with reference to pathology laboratory based in vitro diagnostic operations. Any other handling aspects of this product will require different precautions not addressed in this document. See also disclaimer. The potential health effects of this product have not been extensively evaluated. Indicates product contains Biological Substances The Positive Control and the Calibrator in this kit contain Antigen. Specific care and attention should be paid to health and hygienic practices when handling these products.

2 Page No. : 2 / 6 II. Composition / Ingredients Information AICS HSIS SUSMP Ingredient Name/Nature Wash Buffer TMB Chromogen Stop Solution Sample Diluent 3 Anti-NS1 HRP Conjugate Microwells Positive Control ]and Calibrator Negative Controls na 4 na na Dengue NS1 Recombinant Antigen (Biological Substance) Human Serum Derived Materials (Biological Substance) Animal Derived Materials (Biological Substance) Bovine Serum Albumin (CAS ) Gentamycin Sulphate, Gentamicin (CAS ) % % 0.005% 6 Ortho-phosphoric acid (CAS ) % Proclin TM 300(CAS ) Mixture of 5-chloro-2-methyl-4- isothiazolin-3-one(cas ) and 2-methyl-4-2H-isothiazol-3-0.1% % 0.1% - 0.1% - one(cas ) Sodium Azide (CAS ) % Tetramethylbenzidine (CAS ) - 95% Proprietary Ingredients determined not to be hazardous at that concentration AICS Australian Inventory of Chemical Substances. Indicates that substance is included in AICS OR na not a chemical substance. HSIS - Hazardous Substances Information System - Consolidated Lists. Indicates that substance is included in HSIS OR not included. SUSMP Standard for the Uniform Scheduling of Medicines & Poisons. Not applicable to schedules OR # indicating schedule number.

3 Page No. : 3 / 6 III. Hazard Identification Risk Phrases R22 R32 Harmful if swallowed. Contact with acids liberates very toxic gas R36/38 Irritating to eyes and skin R36/37/38 R43 Irritating to eyes, respiratory system and skin May cause sensitization by skin contact Safety Phrases S2 S13 S18 Keep out of reach of children. Keep away from food, drink and animal feeding stuffs. Handle and open container with care S24/25 Avoid contact with skin and eyes. S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S29/56 Do not empty into drains, dispose of this material and its container at a hazardous or special waste collection point. S36/37/39 S45 Wear suitable protective clothing, gloves and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S47/49 Keep only in the original container at a temperature between 2-8 IV. First Aid Measures Swallowed Do not induce vomiting. Wash out mouth thoroughly with water. Give a sip of water to drink. Never give anything by mouth to an unconscious person. Seek medical advice. Eye Hold eyelids apart and flush the eye continuously with running water for at least 15 minutes. Seek medical advice if irritation develops. Skin Immediately flush skin with plenty of water for at least 15 minutes. Wash gently with soap and water and rinse well. Remove contaminated clothing and clean before re-use. Seek medical advice if irritation develops. Inhaled Advice to Doctor Remove to fresh air. Seek medical advice if symptoms persist. Treat symptomatically. V. Fire Fighting Measures Data Extinguishing media Hazardous combustion As merited None anticipated products Hazchem Code None allocated

4 Page No. : 4 / 6 VI. Accidental Release Measures Emergency Procedure Methods & Materials for containment and cleanup Treat as BioHazard; Personal Safety > Contain > Disinfect / Sanitise / Report According to facility Biohazard Plan: typically this will include Personal Protective Equipment > Chemical Sanitiser > Approved Disposal Procedure > Investigation & Reporting VII. Handling and Storage Precautions for Safe Handling FOR PROFESSIONAL USE ONLY Biological substances of human origin have been tested for antibody to human immunodeficiency virus 1& 2(HIV 1&2), hepatitis C (HCV) as well as hepatitis B surface antigen and found to be negative. However no test method can offer complete assurance and all human controls and antigen should be handled as potentially infectious material at the Biosafety Level 2. Safe Storage Practice FOR LABORATORY USE ONLY. Store between 2-8 C. VIII. Exposure Controls and Personal Protection UNDER NO CIRCUMSTANCES SHOULD THESE PRODUCTS BE STORED OR USED IN ANY AREA WHERE FOOD OR DRINK IS EVER STORED OR CONSUMED. National Exposure Standards With respect to STOP SOLUTION, TWA 1mg/m 3, STEL 3mg/m 3 With respect to Sodium Azide, TWA 0.11ppm, 0.3mg/m 3 peak limitation. For use only under PC2 / Pathology Laboratory conditions. Personal Protection Wear suitable protective clothing for example back tying gown with cuffed long sleeves, gloves IX. Physical and Chemical Properties which are impermeable to biological and laboratory reagents and eye/face protection which prevents splashes entering the eye. Appearance This kit comprises a range of sealed packages. If any of the packages are broken or damaged DO NOT USE, dispose as BIOLOGICAL WASTE. If any of the solutions contains inclusions DO NOT USE, dispose as BIOLOGICAL WASTE. Odour Solubility in water Specific Gravity ph DO NOT INTENTIONALLY INHALE ANY OF THESE MATERIALS All components are essentially water soluble All preparations are g/ml STOP SOLUTION IS STRONGLY ACIDIC. All other components have essentially neutral ph. Flammability Not considered Flammable.

5 Page No. : 5 / 6 X. Stability and Reactivity Chemical Stability Considered Chemically Stable. Biochemical activity will decline with improper storage but any potential biological hazard may be unaffected by increased temperatures. Conditions to avoid DO NOT USE in any manner or for any means contrary to the directions provided. XI - I. Toxicological Information Avoid cross contamination with other substances, always use fresh, clean and dry implements to aliquot this and other biological substances. Avoid generating aerosols. Swallowed - Acute All products except the Controls may be irritating if swallowed. The Controls are harmful if swallowed. Eye - Acute Skin - Acute Inhaled - Acute Swallowed - Chronic Irritating to eyes. Irritating to skin. TMB Chromogen is irritating if inhaled. Other products may be irritating if inhaled. Prolonged exposure may have an irritant action on human tissues. Eye Chronic Skin - Chronic Inhaled - Chronic XI II. Toxicological Information Biological Agents Swallowed - Acute Eye - Acute Skin - Acute Inhaled - Acute Swallowed - Chronic The potential health effects of these products have not been extensively evaluated. Eye Chronic Skin - Chronic Inhaled - Chronic XII. Ecological Information Ecological Considerations STOP SOLUTION content is listed on the NATIONAL POLLUTANT INVENTORY but is significantly below the reporting threshold. XIII. Disposable Considerations Disposal Considerations S29/56 Do not empty into drains, dispose of these materials and their containers as hazardous or at special waste collection point. Always disinfect any materials and/or dispose and manage as biological waste

6 Page No. : 6 / 6 XIV. Transport Information UN No. Shipping Name Dangerous Goods Class Sub Risks Pack Group Hazchem Code None are applicable. None are applicable. Nil. Nil. Does not apply to this substance. None are applicable XV. Regulatory Information Country of Origin This product has been manufactured in Korea but may contain imported ingredients Manufacture & Use This product has been manufactured using systems which have been assessed and certified as meeting the requirements of ISO Medical devices Quality management systems requirements for regulatory purposes by a competent authority. National Chemicals Information System Classification according to EU guidelines Irritant Xi Harmful Xn XVI. Other Information Use good personal and laboratory hygiene. It is recommended that all staff remove all contaminated clothing at the end of every working session and wash all traces of any substance from their skin using cool running water and sanitizing soap, prior to adopting clean clothing. Biological Safety Data Disclaimer: This MSDS recommends that best practice be investigated and adopted. This MSDS provides safety data only for the product and circumstances of use nominated. The MSDS summarizes our best knowledge of the health and safety hazard information pertaining to professional workplace use of the nominated substance however the author expressly disclaims that the MSDS is a representation or guarantee. Each user should read the MSDS and consider the information in the context of their specific conditions and circumstances, and in conjunction with other products. If clarification is required or further information sought in order to make a risk assessment the user should contact the nominated sponsor company.