Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses
by Beijing Applied Biological Technologies Co., Ltd.
Ref CG9092(S)-AN
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974323018575 06974323018575 | Date14 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses
- Model / Reference
- CG9092(S)-AN
- Primary DI / UDI-DI
- 06974323018575
- Basic UDI-DI
- B-06974323018575
- EMDN Code
- W0105090601 Coronavirus / influenza - rt & poc
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012338
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No