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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device direct-to-consumer access pharmacogenetic assessment system
Definition A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.
Product CodeQDJ
Regulation Number 862.3364
Device Class 2


Premarket Reviews
ManufacturerDecision
23ANDME, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
  1.  DEN180028  23andMe Personal Genome Service (PGS) Pharmacogene ...

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