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.
To improve and expand manufacturing of kit components
| Device | Elecsys Anti-HBs II |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Roche Diagnostics |
| Date Received | 2021-11-29 |
| Decision Date | 2021-12-16 |
| PMA | P190034 |
| Supplement | S001 |
| 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 | Roche Diagnostics 9115 Hague Road po Box 50416 indianapolis, IN 46250 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190034 | Original Filing | |
| S001 | 2021-11-29 | 30-day Notice |