PMA P100039S012
- Device
- ADVIA Centaur aHBs2 Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P100039
- Supplement
- S012
- Product code
- LOM
- Decision date
- 2021-04-13
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Implement two additional tiers of standards identical to the approved standard used in manufacturing.
Current openFDA PMA Record#
- Device
- ADVIA Centaur aHBs2 Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P100039
- Supplement
- S012
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-04-13
- Decision code
- OK30
- Date received
- 2021-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement two additional tiers of standards identical to the approved standard used in manufacturing.