Identity
- Trade Name
- SCoV-2 Ag Detect™ Rapid Test FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- POC COVID-19 antigen test, 50tests/kit FDA UDI
- Model / Reference
- COVAF-50 FDA UDI
- Description
- POC COVID-19 antigen test, 50tests/kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B379COVAF501 FDA UDI
- GMDN Term
- 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-2 antigen IVD, kit, rapid ICT, clinical
SCoV-2 Ag Detect™ Rapid Test by InBios International, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical.
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- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box — WatMIND USA · Class II
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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
- InBios International, Inc.
Sources (1)
- FDA UDI 9f2d3e40-86ca-4112-833d-45273aaddda7 33 fields · synced Jun 9, 2026