PMA P930036S026

Device: ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S026
Product code: LOK
Decision date: 2026-05-11
Classification: Immunology
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: a change that will implement control system (medical decision pools and tiered standards) and a traceability (update to 22/216, 2nd WHO International Standard) change.

Current openFDA PMA Record#

Device: ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S026
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2026-05-11
Decision code: APPR
Date received: 2026-01-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: a change that will implement control system (medical decision pools and tiered standards) and a traceability (update to 22/216, 2nd WHO International Standard) change.