- Device
- ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P210019
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-12-20
- Decision code
- APPR
- Date received
- 2022-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the use of the ADVIA Centaur Anti-HBc Total 2 (HBcT2) assay on the ADVIA Centaur CP.