- Device
- IMMULITE 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S025
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2026-04-21
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of the instrument manufacturing site change for the IMMULITE 2000XPi analyzer to the Siemens Healthcare Diagnostics instrument manufacturing facility located in Llanberis, Wales