PMA P030049S013
- Device
- ADVIA Centaur HBsAg
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030049
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2019-10-25
- 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
- Implement two additional tiers of standards identical to the approved standard used in manufacturing.
Current openFDA PMA Record#
- Device
- ADVIA Centaur HBsAg
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030049
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-27
- 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.