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Rapid SARS-CoV-2 Antigen Test Card
EUDAMEDFDA UDIClass IVD devices for self-testing (EU MDR)
Ref 1N40C5-9Ref 1N40C5-4Ref 1N40C5-10 (for 20 Tests/Box)
Identity
- Trade Name
- Rapid SARS-CoV-2 Antigen Test Card EUDAMEDBoson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/Kit FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Rapid SARS-CoV-2 Antigen Test Card EUDAMEDNon-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. FDA UDI
- Model / Reference
- 1N40C5-9 EUDAMED1N40C5-4 EUDAMED1N40C5-10 (for 20 Tests/Box) EUDAMED1N40C5-40-US FDA UDI
- Description
- Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06921963712660 EUDAMED06921963712264 EUDAMED06921963712745 EUDAMED06921963712936 FDA UDI
- Basic UDI-DI
- B-06921963712660 EUDAMEDB-06921963712264 EUDAMEDB-06921963712745 EUDAMED
- FDA Product Code
- QKP FDA UDI
- EMDN Code
- W0105040619 EUDAMED
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDN FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Rapid SARS-CoV-2 Antigen Test Card by Xiamen Boson Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06921963712660 | Class IVD devices for self-testing | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD devices for self-testing | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED a1f825f5-981b-4efb-b1e1-976d7914b8ee 61 fields · synced Jul 16, 2026
- EUDAMED 0c3c5c35-46bb-40e5-a119-2d60d3e5b186 61 fields · synced May 18, 2026
- EUDAMED 668b4753-315f-40a9-b643-860d8b3490ac 61 fields · synced May 19, 2026
- FDA UDI 1168e228-abe8-4cc6-96f2-4bc04e38c94d 35 fields · synced May 26, 2026