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.
| Device | ARCHITECT HBsAg Next Qualitative/Next Confirmatory |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-07 |
| Decision Date | 2022-12-07 |
| PMA | P210003 |
| Supplement | S003 |
| Product Code | LOM |
| 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 Laboratories 100 Abbott Park Road dept: 09aa Bldg: Ap8-1 abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Replacement Of A Current Testing Assay With A New Equivalent Assay |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210003 | Original Filing | |
| S005 | 2023-01-06 | 30-day Notice |
| S004 | ||
| S003 | 2022-11-07 | 30-day Notice |
| S002 | 2022-09-14 | 30-day Notice |
| S001 | 2022-09-09 | 30-day Notice |