- Device
- IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010052
- Supplement
- S020
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-09-18
- Decision code
- APPR
- Date received
- 2024-07-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to relocate processes for critical raw materials to a site previously approved in the submission