PMA P190034S001
- Device
- Elecsys Anti-HBs II
- Applicant
- Roche Diagnostics
- PMA number
- P190034
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2021-12-16
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Improve and expand manufacturing of kit components.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HBs II
- Applicant
- Roche Diagnostics
- PMA number
- P190034
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Improve and expand manufacturing of kit components.