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 | ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Supplement NumberS001 Date Received08/01/2022 Decision Date12/20/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-08-01 |
| Decision Date | 2022-12-20 |
| PMA | P210019 |
| Supplement | S001 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591 PMA NumberP210019 Supplement NumberS001 Date Received08/01/2022 Decision Date12/20/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement For Use Of The ADVIA Centaur Anti-HBc Total 2 (HBcT2) Assay On The ADVIA Centaur CP. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210019 | Original Filing | |
| S001 | 2022-08-01 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414604336 | P210019 | 000 |
| 00630414604138 | P210019 | 000 |
| 00630414210766 | P210019 | 000 |
| 00630414561226 | P210019 | 000 |