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.
| Device | VERSANT HCV RNA QUALITATIVE ASSAY |
| Classification Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| 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 |
| Notice Date | 2003-02-28 |
| PMA | P020011 |
| Supplement | S |
| Product Code | MZP |
| Docket Number | 03M-0070 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE 10210 Genetic Center Dr. san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020011 | | Original Filing |
| S016 |
2020-07-09 |
30-day Notice |
| S015 |
2020-02-12 |
30-day Notice |
| S014 |
2019-05-21 |
30-day Notice |
| S013 |
2019-03-27 |
30-day Notice |
| S012 |
2019-02-21 |
30-day Notice |
| S011 |
2018-10-02 |
30-day Notice |
| S010 |
2017-10-10 |
30-day Notice |
| S009 |
2015-09-04 |
135 Review Track For 30-day Notice |
| S008 |
2015-04-10 |
30-day Notice |
| S007 |
2013-03-13 |
30-day Notice |
| S006 |
2012-12-18 |
30-day Notice |
| S005 |
2012-04-05 |
Normal 180 Day Track No User Fee |
| S004 |
2010-08-23 |
30-day Notice |
| S003 |
2010-03-31 |
30-day Notice |
| S002 |
2010-02-23 |
135 Review Track For 30-day Notice |
| S001 |
2009-05-01 |
30-day Notice |
NIH GUDID Devices