Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Emotional Changes 1 1
Laceration(s) 1 1
Scar Tissue 1 1

-
-