PMA P930036S025

Device: ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S025
Product code: LOK
Decision date: 2025-07-16
Classification: Immunology
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for the implementation of a particle size analyzer utilized for the in-process testing of paramagnetic particles.

Current openFDA PMA Record#

Device: ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S025
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2025-07-16
Decision code: OK30
Date received: 2025-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the implementation of a particle size analyzer utilized for the in-process testing of paramagnetic particles.