PMA P930036S020

Device: ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S020
Product code: LOK
Decision date: 2022-09-30
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Manufacturing process change to the affinity purification method used to purify the anti-AFP polyclonal antibodies (Lite Reagent).

Current openFDA PMA Record#

Device: ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S020
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2022-09-30
Decision code: OK30
Date received: 2022-09-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing process change to the affinity purification method used to purify the anti-AFP polyclonal antibodies (Lite Reagent).