PTA

Product Code: PTA


Products Classified as PTA

3107Genetic Variant Detection And Health Risk Assessment SystemGenetic Health Risk Assessment System.

Total Product Life Cycle (TPLC) Devices

3107Genetic Variant Detection And Health Risk Assessment SystemGenetic Health Risk Assessment System.

Pre-market Notifications for PTA

K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company
K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc.
K192073Helix Genetic Health Risk App For Late-onset Alzheimer’s DiseaseHelix OpCo, LLC

Global Unique Device Identification Database

00862150000060Genetic Variant Detection And Health Risk Assessment System
00859462006118Genetic Variant Detection And Health Risk Assessment System
00859462006279Genetic Variant Detection And Health Risk Assessment System
00859462006262Genetic Variant Detection And Health Risk Assessment System
00859462006378Genetic Variant Detection And Health Risk Assessment System
00859462006385Genetic Variant Detection And Health Risk Assessment System
00859462006392Genetic Variant Detection And Health Risk Assessment System
00860013485405Genetic Variant Detection And Health Risk Assessment System

Maude Adverse Events

MAYO CLINIC GENEGUIDE HELIXUNK2020-03-20
MYGENOME (30X WHOLE GENOME SEQUENCING)UNK2020-03-20
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