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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device setmelanotide eligibility gene variant detection system
Definition A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling.
Product CodeQRV
Regulation Number 862.1164
Device Class 2


Premarket Reviews
ManufacturerDecision
PREVENTIONGENETICS, LLC
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