BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
FDA premarket approval P020022 · decided 2003-03-28
Approval details
- PMA number
- P020022
- Trade name
- BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2002-06-19
- Decision date
- 2003-03-28
- Days to decision
- 282 days
- Decision code
- APWD
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- Yes
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR THE BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA). THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA (EDTA AND ACD) OF HCV-INFECTED INDIVIDUALS USING THE BAYER SYSTEM 340 BDNA ANALYZER. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY. THE VERSANT HCV RNA 3.0 ASSAY IS INTENDED FOR USE AS AN AID IN THE
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