PMA P010053S013
- Device
- IMMULITE 2000/2000 XPi Anti-HBc IgM
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010053
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2021-03-11
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approved for labeling changes as a result of biotin interference testing.
Current openFDA PMA Record#
- Device
- IMMULITE 2000/2000 XPi Anti-HBc IgM
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- PMA number
- P010053
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-03-11
- Decision code
- APPR
- Date received
- 2020-12-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approved for labeling changes as a result of biotin interference testing.