VERSANT HCV RNA QUALITATIVE ASSAY
FDA premarket approval P020011/S005 · decided 2012-06-25
Approval details
- PMA number
- P020011
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2012-04-05
- Decision date
- 2012-06-25
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR A DEVICE NAME CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA QUALITATIVE ASSAY AND APTIMA HCV RNA QUALITATIVE ASSAY AND IS INDICATED FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM.
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