Change of the activator used in the synthesis of dna oligonucleotides from 1-h tetrazole to 5-ethylthio 1-h tetrazole (ett) and the addition of sigma-aldrich (safc) as a secondary supplier of the new activator (ett).
| Device | VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA 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 | 2009-05-01 |
| Decision Date | 2009-05-22 |
| PMA | P020011 |
| Supplement | S001 |
| Product Code | MZP |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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