PMA P110022S028
- Device
- Elecsys Anti-HBc IgM Immunoassays
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110022
- Supplement
- S028
- Product code
- LOM
- Decision date
- 2022-01-11
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Expand and improve the manufacturing packaging process.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HBc IgM Immunoassays
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110022
- Supplement
- S028
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-01-11
- Decision code
- OK30
- Date received
- 2021-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand and improve the manufacturing packaging process.