PMA P980041S050

Device: Access AFP Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
Product code: LOK
Decision date: 2022-12-16
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.

Current openFDA PMA Record

Device: Access AFP Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S050
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2022-12-16
Decision code: APPR
Date received: 2021-04-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.