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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device whole exome sequencing constituent device
Definition A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
Product CodeQNC
Regulation Number 866.6000
Device Class 2


Premarket Reviews
ManufacturerDecision
HELIX OPCO, LLC
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