VERSANT HCV RNA QUALITATIVE ASSAY
FDA premarket approval P020011 · decided 2002-11-07
Approval details
- PMA number
- P020011
- Trade name
- VERSANT HCV RNA QUALITATIVE ASSAY
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Gen-Probe
- Date received
- 2002-03-18
- Decision date
- 2002-11-07
- Days to decision
- 234 days
- Decision code
- APRL
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE VERSANT HCV RNA QUALITATIVE ASSAY. THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA QUALITATIVE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION ASSAY FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM. THE VERSANT HCV RNA QUALITATIVE ASSAY IS INDICATED FOR USE WITH FRESH OR FROZEN SPECIMENS FROM THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV INFECTION WITH EVIDENCE OF LIVER DISEASE, AND
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