Vitros Immunodiagnostic Products Anti-Hcv Reagent Pack and Calibrator

Approval order statement

APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR. THESE DEVICES ARE INDICATED FOR: THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS (STATE OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING VITROS ANTI-HCV REAGENT PACKS. THE VITROS ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.