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ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test
FDA UDIEUDAMEDClass N (US FDA UDI)
Identity
- Trade Name
- ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests FDA UDI
- Model / Reference
- CP0031 FDA UDI
- Description
- ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests FDA UDI
Identifiers
- Catalog Number
- CP0031 FDA UDI
- Primary DI / UDI-DI
- 00850056728706 FDA UDI
- FDA Product Code
- QKP FDA UDIPSZ FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N FDA UDI
- Regulation Number
- 866.3328 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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, clinicalInfluenza A/B virus antigen IVD, kit, rapid ICT, clinical
ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test by Lumos Diagnostics, Inc. — Class N — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class N | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Lumos Diagnostics, Inc.
Sources (2)
- FDA UDI 2767cbe2-93f7-47d4-bb6c-e350ae127d59 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026