Setmelanotide Eligibility Gene Variant Detection System
QRV is the FDA product code for Setmelanotide Eligibility Gene Variant Detection System, a class II device type, regulated under 21 CFR 862.1164. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QRV
- Device name
- Setmelanotide Eligibility Gene Variant Detection System
- 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.
- Regulation
- 21 CFR 862.1164
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QRV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
Applicants with the most clearances
Product code QRV| Applicant | Clearances |
|---|---|
| Preventiongenetics, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QRV.
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