Influenza A/B and Respiratory syncytial virus nucleic acid detection kit (Real-time fluorescence PCR method)
by Guangzhou Deaou Gene Technology Co., Ltd 2 variants
Ref 8 tests/kit, AFR01,AFR01D
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06976055490032 | Date30 Oct 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Influenza A/B and Respiratory syncytial virus nucleic acid detection kit (Real-time fluorescence PCR method)Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR)
- Model / Reference
- 8 tests/kit, AFR01, AFR01D
- Primary DI / UDI-DI
- 06976055490032, D-697603130AFR019TB9
- Basic UDI-DI
- B-06976055490032, B-697603130AFR019TB9
- EMDN Code
- W0105099004, W0105070502
- Device Class
- Class IVD General
- EU market of registration
- AustriaGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033028
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No