SARS-CoV-2 Antigen Rapid Test Cassette
by Beijing Applied Biological Technologies Co., Ltd. 6 variants
Ref G1P
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-06974323018940 06974323018940 | Date25 May 2026 | 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- Withdrawn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
- SARS-CoV-2 Antigen Rapid Test Cassette
- Model / Reference
- G1P
- Primary DI / UDI-DI
- 06974323018940
- Basic UDI-DI
- B-06974323018940
- EMDN Code
- W0105041101 Coronavirus ag
- Device Class
- Class IVD General
- 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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No