Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Basic Information
- Device Name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Trade Name
- VERSANT HCV RNA QUALITATIVE ASSAY
- PMA Number
- P020011
- Device Class
- FDA Class 2
- Product Code
- MZP
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Regulation Number
- 866.3170
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- November 7, 2002
- Date Received
- March 18, 2002
- Expedited Review
- N
- Docket Number
- 03M-0070
Advisory Committee 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 INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV WITH ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA IS EVIDENCE OF ACTIVE HCV INFECTION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | FDA class 2 | Microbiology |