Identity
- Trade Name
- OraQuick Ebola Rapid Antigen Test FDA UDI
- Generic Name
- Ebola virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 3001-2940 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337001426 FDA UDI
- 510(k) Number
- DEN190025 FDA UDI
- FDA Product Code
- QID FDA UDI
- GMDN Term
- Ebola virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.4002 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
No
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: Ebola virus antigen IVD, kit, rapid ICT, clinical
OraQuick Ebola Rapid Antigen Test by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI f6ffa959-f1ef-4d29-a0d4-1279ab368812 35 fields · synced Jun 9, 2026