Identity
- Trade Name
- Genabio COVID-19 Rapid Self-Test Kit FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid FDA UDI
- Model / Reference
- RA9-E00301 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00196852254316 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid 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
No
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, fluorescent immunoassay, rapid
Genabio COVID-19 Rapid Self-Test Kit by Genabio Diagnostics Inc. — Class N — 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 | Class N | Pending data |
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Manufacturer
- Manufacturer
- Genabio Diagnostics Inc.
Sources (1)
- FDA UDI 8830b759-b270-4a76-a6a8-750e9db0fdd1 32 fields · synced Jun 1, 2026