Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)
by PSI Gene Technology Co., Ltd. China EUDAMED
Ref 48 tests/kit, 12 tests/kit, 24 tests/kit EMDN W0106010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975843690036 | Date19 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)Corneal Dystrophy TGFBI Gene Testing Kit（Fluorescence PCR）
- Model / Reference
- 48 tests/kit, 12 tests/kit, 24 tests/kit
- Primary DI / UDI-DI
- 06975843690036, 16975843690019, 06975843690029, 16975843690033, 16975843690026
- Basic UDI-DI
- B-06975843690036, B-16975843690019, B-06975843690029, B-16975843690033, B-16975843690026
- EMDN Code
- W0106010299 Polygenetic disorders tests - other
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023276
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from PSI Gene Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (5)
- EUDAMED 77bc95ec-073f-4f59-9f58-50f288beb41c
- EUDAMED 16975843690019|B-16975843690019
- EUDAMED 06975843690029|B-06975843690029
- EUDAMED 16975843690033|B-16975843690033
- EUDAMED 16975843690026|B-16975843690026