Identity
- Trade Name
- OraQuick In Home HIV Test, Pharmacy FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Model / Reference
- 1001-0528 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337001334 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test 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
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: HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
OraQuick In Home HIV Test, Pharmacy 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, immunochromatographic test (ICT), rapid, professional/self-test.
- Chembio HIV Reactive/Nonreactive Controls — Chembio Diagnostic Systems · Class II
- Chembio DPP HIV 1/2 Assay — Chembio Diagnostic Systems · Class II
- INSTI HIV-1/HIV-2 Antibody Test — Biolytical Laboratories Inc · Class II
- Chembio DPP HIV 1/2 Rapid Test Control Pack — Chembio Diagnostic Systems · Class II
- Chembio SURE CHECK HIV 1/2 Assay — Chembio Diagnostic Systems · Class II
- Chembio HIV 1/2 Stat-Pak Assay — Chembio Diagnostic Systems · Class II
- Clearview HIV Reactive/Nonreactive Controls — Chembio Diagnostic Systems · Class II
- Geenius — Bio-Rad · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI 3b236dde-6c1e-45b0-96a1-47882b18fa37 35 fields · synced Jun 9, 2026