PMA P110041S004
- Device
- ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2018-04-19
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval for migration of the ADVIA Centaur HBsAgII (HBsII), the ADVIA Centaur HBsAg Confirmatory, and the ADVIA Centaur HBsAg Quality Control Material onto the Atellica IM analyzer.
Current openFDA PMA Record#
- Device
- ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-04-19
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for migration of the ADVIA Centaur HBsAgII (HBsII), the ADVIA Centaur HBsAg Confirmatory, and the ADVIA Centaur HBsAg Quality Control Material onto the Atellica IM analyzer.