PMA P980041S041

Device

Acess AFP Reagents on the Access Immunoassay Systems

Applicant

Beckman Coulter, Inc.

PMA number

P980041

Supplement

S041

Product code

LOK

Decision date

2018-12-21

Classification

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

Generic name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Approval order statement

Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.

Summary

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