QRVClass II
Setmelanotide Eligibility Gene Variant Detection System
Clinical Chemistry · 21 CFR 862.1164
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.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
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Event type breakdown
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510(k) clearances
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