QwikCheck DFI Kit: 10 Tests
by M.E.S. Medical Electronic Systems Ltd. United States GUDID
Product code IAF
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016650617 | Date8 Jun 2023 | StatusIn distribution |
Coverage
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- QwikCheck DFI Kit
- Generic Name
- Sperm energy status and motility testing reagent IVD
- Model / Reference
- QwikCheck DFI Kit: 10 Tests
- Primary DI / UDI-DI
- 07290016650617
- FDA Product Code
- IAF
- GMDN Term
- Sperm energy status and motility testing reagent IVD
- Device Class
- Class I
- Regulation Number
- 864.1850
- Commercial Distribution
- In Commercial Distribution
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
Sources (1)
- FDA UDI 0c972e4f-3f1e-431f-b489-6476abb53d47