SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
by Ningbo BESTest Bio-technology Co., Ltd. 2 variants
Ref SI003-25Model 25 tests/kit
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-000041242SI003-254C D-000041242SI003-254C | Date13 Jan 2025 | 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- Withdrawn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 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
- Model / Reference
- 25 tests/kit, SI003-25
- Primary DI / UDI-DI
- D-000041242SI003-254C
- Basic UDI-DI
- B-000041242SI003-254C
- EMDN Code
- W0105070399 Multiple viruses - multiplex assays - other
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000041242
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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