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Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit
FDA UDIClass N (US FDA UDI)
Identity
- Trade Name
- Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- 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
- Model / Reference
- 1N40C5-2-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
- 06921963715296 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit by Xiamen Boson Biotech Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID
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Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing.
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- iHealth — IHEALTH LAB INC. · N
- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- WELLlife™ — WONDFO USA CO., LTD. · N
- Hotgen™ COVID-19 Antigen Home Test — Beijing Hotgen Biotech Co., Ltd. · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Sources (1)
- FDA UDI dd0fa011-47c3-41ca-942d-530d8fc489f3 35 fields · synced Jun 8, 2026