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.
Manufacturing change to increase the fill volume of activation reagent in the alinity m hcv act tray 2.
| 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 | 2020-05-07 |
| Decision Date | 2020-06-09 |
| PMA | P190025 |
| Supplement | S002 |
| 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 |