VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
FDA premarket approval P010021 · decided 2001-08-30
Approval details
- PMA number
- P010021
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2001-04-02
- Decision date
- 2001-08-30
- Days to decision
- 150 days
- Decision code
- APRL
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- 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 U
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