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.
| 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 | 2012-04-05 |
| Decision Date | 2012-06-25 |
| PMA | P020011 |
| Supplement | S005 |
| Product Code | MZP |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE 10210 Genetic Center Dr. san Diego, CA 92121 |
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