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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 system’s 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 system’s sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.