PMA P010053
- Device
- IMMULITE® 2000 Anti-HBc IgM
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010053
- Supplement
- S016
- Product code
- LOM
- Decision date
- 2023-08-30
- Generic name
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Approval order statement
- Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.
Current openFDA PMA Record#
- Device
- IMMULITE® 2000 Anti-HBc IgM
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010053
- Supplement
- S015
- Decision date
- 2023-08-30
- Decision code
- APPR
- Date received
- 2022-03-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.