Setmelanotide Eligibility Gene Variant Detection System
Setmelanotide Eligibility Gene Variant Detection System is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
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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