CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)
by Wuxi Ruiqi Gene Biotechnology Co., Ltd. China EUDAMED
Ref P157H, P129H
EMDN W0106010205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974870710205 | Date26 Sep 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)
- Model / Reference
- P157H, P129H
- Primary DI / UDI-DI
- 06974870710205, 06974870710199
- Basic UDI-DI
- B-06974870710205, B-06974870710199
- EMDN Code
- W0106010205 Hypertension
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000027697
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (2)
- EUDAMED f94d8bd2-bf9e-4044-b815-3fe4692c33d3
- EUDAMED 06974870710199|B-06974870710199