Identity
- Trade Name
- OraQuick HIV Self-Test FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- 3001-3822U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337001808 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 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
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: HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing
OraQuick HIV Self-Test by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing.
- OraQuick HIV Self-Test — OraSure Technologies, Inc. · Class II
Cleared under the same submission
BP120001 also covers:
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 |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI 6b79fb07-a6ca-47e0-8a01-122b679a7250 35 fields · synced Jun 9, 2026