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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Setmelanotide Eligibility Gene Variant Detection System

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1164

Medical specialty

Clinical Chemistry

FDA 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.

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