PMA P110041S003
- Device
- ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2016-10-26
- 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 the migration of the ADVIA Centaur® HBsAg II (HBsII), ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control Material to the ADVIA Centaur® XPT system.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY
- Applicant
- Siemens Corp.
- PMA number
- P110041
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2016-10-26
- Decision code
- APPR
- Date received
- 2015-07-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the migration of the ADVIA Centaur® HBsAg II (HBsII), ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control Material to the ADVIA Centaur® XPT system.