ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
FDA premarket approval P050042 · decided 2006-06-07
Approval details
- PMA number
- P050042
- Trade name
- ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2005-11-23
- Decision date
- 2006-06-07
- Days to decision
- 196 days
- Decision code
- APRL
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT ARCHITECT ANTI-HCV. THIS DEVICE IS INDICATED FOR: THE ARCHITECT ANTI-HCV ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE
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