Annex to the Accreditation Certificate D-PL according to DIN EN ISO/IEC 17025:2005

Transcription

1 Deutsche Akkreditierungsstelle GmbH Annex to the Accreditation Certificate D-PL according to DIN EN ISO/IEC 17025:2005 Date of issue: Holder of certificate: CSL Behring GmbH Plasma Product Development Marburg, Central laboratory for clinical testing Emil von Behring Straße 76, Marburg Tests in the fields: Health Care (medical laboratory testing in the context of clinical studies) Clinical chemistry Immunology Within the given testing field marked with **, the technical laboratory is permitted, without being required to inform and obtain prior approval from Deutsche Akkreditierungsstelle GmbH (DAkkS), the modification, development and refinement of testing methods. The listed testing methods are exemplary. The testing laboratory maintains a current list of all testing methods within the flexible scope of accreditation. This document is a translation. The definitive version is the original German annex to the accreditation certificate. Page 1 / 5

2 medical laboratory testing in the context of clinical studies (clinical chemistry) Testing field: coagulation tests** factor II coagulation test factor VII coagulation test factor VIIa coagulation test factor VII-INH coagulation test factor VIII coagulation test factor VIII-INH coagulation test factor IX coagulation test factor IX-INH coagulation test factor X coagulation test fibrinogen coagulation test vwf-ricof agglutination test PT/INR coagulation test MCF thrombelastography Testing field: ligand assays** protein S fibrinogen prothrombin fragment F 1+2 thrombin antithrombin III complex factor IX factor XIII vwf-cba vwf-inh Date of issue: Translation - Page 2 / 5

3 Testing field: spectrometry (photometry)** factor VIII chromogen protein C chromogen C1 inhibitor activity chromogen C1 inhibitor-inh chromogen ATIII chromogen factor XIII chromogen Thrombin Generation Assay fluorogen (TGA) FVII chromogen Testing field: spectrometry (turbidimetry)** D-Dimer immunoturbidimetry medical laboratory testing in the context of clinical studies (immunology) Testing field: ligand assays** interleukin 1β (IL-1β) heparin plasma interleukin 6 (IL-6) heparin plasma FXIII antibody, isotype IgG Tumor Nekrosis Factor alpha heparin plasma (TNFa) C1 Inhibitor auto-antibody/, serum Screening C1 inhibitor auto-antibody/, serum Isotype IgA C1 inhibitor auto-antibody/, serum Isotype IgG C1 inhibitor auto-antibody/ Isotype IgM, serum Date of issue: Translation - Page 3 / 5

4 human albumin antibody human FIX antibody rfviia-fusion protein antibody rfviii antibody CHO antibody (rix-fp) CHO antibody (rviia-fp) CHO antibody (rviii sc) CHO antibody (rviia-fp) FVII antigen C3a antigen, serum C5a antigen EDTA plasma,, serum Determination of rd'd3-fp antibodies ECLIA Testing field: spectrometry (turbidimetry)** vwf antigen immunoturbidimetry vwf-inh immunoturbidimetry Free Protein S antigen immunoturbidimetry Testing field: spectrometry (surface plasmon resonance)** Determination of rix-fp CHO HCP antibodies Determination of rviii CHO HCP antibodies Determination of rviia-fp CHO HCP antibodies Date of issue: Translation - Page 4 / 5

5 Testing field: spectrometry (nephelometry)** C1 inhibitor antigen nephelometry IgG level serum, sputum, BAL nephelometry C3 antigen serum nephelometry C4 antigen, serum nephelometry C5 antigen serum nephelometry Abbreviations used: DIN EN ISO IEC Deutsches Institut für Normung e.v. European Standard International Organization for Standardization International Electrotechnical Commission Date of issue: Translation - Page 5 / 5