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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autosomal recessive carrier screening gene mutation detection system
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.
Product CodePKB
Regulation Number 866.5940
Device Class 2


Premarket Reviews
ManufacturerDecision
23ANDME
  GRANTED 1

MDR Year MDR Reports MDR Events
2016 1 1
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Improper or Incorrect Procedure or Method 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Cognitive Changes 1 1

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