PKB

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Autosomal Recessive Carrier Screening Gene Mutation Detection System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5940

Medical specialty

Immunology

FDA definition

Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

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