Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)
by PSI Gene Technology Co., Ltd. China EUDAMED
Ref 12 tests/kit, 48 tests/kit, 24 tests/kit EMDN W0106010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975843690043 | Date19 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)
- Model / Reference
- 12 tests/kit, 48 tests/kit, 24 tests/kit
- Primary DI / UDI-DI
- 06975843690043, 06975843690067, 16975843690057, 06975843690050, 16975843690040, 16975843690064
- Basic UDI-DI
- B-06975843690043, B-06975843690067, B-16975843690057, B-06975843690050, B-16975843690040, B-16975843690064
- 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 (6)
- EUDAMED 19e534b8-439a-48ca-b64b-960be539a0d9
- EUDAMED 06975843690067|B-06975843690067
- EUDAMED 16975843690057|B-16975843690057
- EUDAMED 06975843690050|B-06975843690050
- EUDAMED 16975843690040|B-16975843690040
- EUDAMED 16975843690064|B-16975843690064