PMA P110041S016
- Device
- Atellica IM Hepatitis B surface Antigen II (HBsII)
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S016
- Product code
- LOM
- Decision date
- 2025-10-17
- Classification
- Microbiology
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval for the biotin remediated Atellica IM Hepatitis B surface Antigen II (HBsII) assay.
Current openFDA PMA Record#
- Device
- Atellica IM Hepatitis B surface Antigen II (HBsII)
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S016
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-10-17
- Decision code
- APPR
- Date received
- 2025-07-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the biotin remediated Atellica IM Hepatitis B surface Antigen II (HBsII) assay.