Implementation of additional in-process testing and associated specifications for lyophilized kit reagents.
| Device | Aptima HCV Quant Dx 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 | HOLOGIC, INC. |
| Date Received | 2018-08-31 |
| Decision Date | 2018-09-26 |
| PMA | P160023 |
| Supplement | S006 |
| 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 | HOLOGIC, INC. 10210 Genetic Center Dr san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160023 | | Original Filing |
| S019 |
2020-07-09 |
30-day Notice |
| S018 | | |
| S017 |
2020-02-12 |
30-day Notice |
| S016 |
2019-12-23 |
Real-time Process |
| S015 |
2019-06-21 |
Normal 180 Day Track |
| S014 |
2019-05-21 |
30-day Notice |
| S013 |
2019-04-19 |
30-day Notice |
| S012 |
2019-03-27 |
30-day Notice |
| S011 |
2019-03-18 |
Real-time Process |
| S010 |
2019-02-21 |
30-day Notice |
| S009 |
2018-12-31 |
Real-time Process |
| S008 |
2018-11-29 |
30-day Notice |
| S007 |
2018-10-03 |
30-day Notice |
| S006 |
2018-08-31 |
30-day Notice |
| S005 |
2018-07-09 |
30-day Notice |
| S004 |
2018-05-09 |
135 Review Track For 30-day Notice |
| S003 |
2018-04-20 |
30-day Notice |
| S002 |
2018-03-12 |
30-day Notice |
| S001 |
2017-08-28 |
Normal 180 Day Track |
NIH GUDID Devices