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 Code | QRV |
Regulation Number |
862.1164
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Device Class |
2
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