PMA P030040S016
- Device
- ADVIA Centaur and Atellica IM HBc IgM
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030040
- Supplement
- S016
- Product code
- LOM
- Decision date
- 2020-03-19
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Scale-up and implementation of a common mixing process for all kit bulk reagents.
Current openFDA PMA Record#
- Device
- ADVIA Centaur and Atellica IM HBc IgM
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030040
- Supplement
- S016
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-03-19
- Decision code
- OK30
- Date received
- 2020-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale-up and implementation of a common mixing process for all kit bulk reagents.