- Device
- ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030040
- Supplement
- S019
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-03-11
- Decision code
- APPR
- Date received
- 2020-12-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes as a result of biotin interference testing.