Approval for migration of the advia centaur anti-hbe2 (ahbe2) assay to the atellica im analyzer. The device, as modified, will be marketed under the trade name atellica im anti-hbe2 (ahbe2).
| Device | ADVIA Centaur Anti-HBe2 (AHBe2) Assay |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Date Received | 2021-08-10 |
| Decision Date | 2022-01-06 |
| PMA | P200017 |
| Supplement | S001 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200017 | | Original Filing |
| S002 |
2022-03-22 |
30-day Notice |
| S001 |
2021-08-10 |
Normal 180 Day Track |
NIH GUDID Devices