Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, control FDA UDI
- Device Name
- VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) FDA UDI
- Model / Reference
- 691 2261 FDA UDI
- Description
- VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) FDA UDI
Identifiers
- Catalog Number
- 691 2261 FDA UDI
- Primary DI / UDI-DI
- 10758750033164 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: HIV1/HIV2 antibody IVD, control
Vitros by Ortho-Clinical Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antibody IVD, control.
- VIROTROL — Bio-Rad Laboratories · Class II
- VIROTROL — Bio-Rad Laboratories · Class II
- OraQuick Advance HIV 1/2 Kit Controls — OraSure Technologies, Inc. · Class III
- VIROTROL — Bio-Rad Laboratories · Class II
- INSTI HIV-1/HIV-2 Control Test Kit — Biolytical Laboratories Inc · Class II
- Geenius — Bio-Rad · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI d4e75324-7299-4e29-8338-67a094f482e3 35 fields · synced Jun 8, 2026