Identity
- Trade Name
- Sofia FDA UDI
- Generic Name
- SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Sofia® SARS Antigen FIA FDA UDI
- Model / Reference
- 20374 FDA UDI
- Description
- Sofia® SARS Antigen FIA FDA UDI
Identifiers
- Catalog Number
- 20374 FDA UDI
- Primary DI / UDI-DI
- 30014613339083 FDA UDI
- GMDN Term
- SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- 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-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Sofia by Quidel Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA UDI 798d274e-39a2-4919-80fd-d0cf22c191dd 35 fields · synced May 30, 2026