This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Addition of alternative testing location for a device component
| Device | Alinity m HCV |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2021-02-05 |
| Decision Date | 2021-03-05 |
| PMA | P190025 |
| Supplement | S005 |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 E. Touhy Avenue des Plaines, IL 60018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190025 | Original Filing | |
| S006 | 2021-04-15 | Real-time Process |
| S005 | 2021-02-05 | 30-day Notice |
| S004 | ||
| S003 | 2020-12-21 | 30-day Notice |
| S002 | 2020-05-07 | 30-day Notice |
| S001 | 2020-04-06 | 30-day Notice |