SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)
by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED
Ref RQ005
EMDN W0105040619
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974473306935 | Date30 Aug 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)
- Model / Reference
- RQ005
- Primary DI / UDI-DI
- 06974473306935, 06974473308380, D-CNMF000054349RQ005MB
- Basic UDI-DI
- B-06974473306935, B-06974473308380, B-CNMF000054349RQ005MB
- EMDN Code
- W0105040619, W0105070399
- Device Class
- Class IVD General
- Market of Registration
- AustriaNetherlandsGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000023810
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Nanjing Synthgene Medical Technology Co., Ltd.
See all devices from Nanjing Synthgene Medical Technology Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (3)
- EUDAMED c9d02210-abe9-4a9a-955c-41fd6c7e9aeb
- EUDAMED 06974473308380|B-06974473308380
- EUDAMED D-CNMF000054349RQ005MB|B-CNMF000054349RQ005MB