Approval for the use of the aptima hcv quant dx assay on the panther system with the attachment of the panther fusion module. The changes being approved include the addition of new hardware and updated software.
| 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 | 2017-08-28 |
| Decision Date | 2018-02-23 |
| PMA | P160023 |
| Supplement | S001 |
| Product Code | MZP |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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