PMA P160019
- Device
- Elecsys HBsAg II/Elecsys HBsAg Auto Confirm
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2025-05-22
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- to relocate processes and expand production within the same establishment
Current openFDA PMA Record#
- Device
- Elecsys HBsAg II/Elecsys HBsAg Auto Confirm
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S019
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-05-22
- Decision code
- OK30
- Date received
- 2025-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to relocate processes and expand production within the same establishment