Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card
by Xiamen Boson Biotech Co., Ltd. 14 variants
Ref 1N41C5-20S-CEModel 1N41C5-1S-CE
Active
CE IVDR
Valid until
19 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 061317 0014 | Date20 Aug 2026 | StatusActive |
Certificates
- V76 061317 0014 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 20 Aug 2026
- Expires
- 19 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 1N41C5-1S-CE, 1N41C5-20S-CE
- Primary DI / UDI-DI
- 06921963720610, 06921963720498, 06921963720641, 06921963720528, 06921963720672, 06921963720580, 06921963720559, 06921963720467
- Basic UDI-DI
- 692196371786K5
- Direct Marketing DI
- 0692196372061006921963720498069219637206410692196372052806921963720672069219637205800692196372055906921963720467
- EMDN Code
- W0105090601 Coronavirus / influenza - rt & poc
- Device Class
- Class C
- EU market of registration
- IcelandCroatiaItalyLithuaniaSloveniaFranceGermanyPoland
Manufacturer details
- EUDAMED SRN
- CN-MF-000001096
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Xiamen Boson Biotech Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No