Norovirus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)
by Guangzhou Deaou Gene Technology Co., Ltd China EUDAMED
Model 8 tests/kit EMDN W0105040516
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06976055490100 | Date25 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Norovirus Nucleic Acid Detection Kit (Real-time Fluorescence PCR Method)
- Model / Reference
- 8 tests/kit
- Primary DI / UDI-DI
- 06976055490100
- Basic UDI-DI
- B-06976055490100
- EMDN Code
- W0105040516 Norovirus - na reagents
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000033028
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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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 (1)
- EUDAMED a5b4cb78-cc1f-4a80-97fc-4544496d7242