- Device
- IMMULITE® AFP, IMMULITE® 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S016
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- 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.