Identity
- Trade Name
- Geenius FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, control FDA UDI
- Device Name
- Geenius HIV 1/2 Controls FDA UDI
- Model / Reference
- 72339 FDA UDI
- Description
- Geenius HIV 1/2 Controls FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610520013854 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, control 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
No
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, control
Geenius by Bio-Rad — Class II — 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
- VITROS — Ortho-Clinical Diagnostics · Class I
- VIROTROL — Bio-Rad Laboratories · Class II
- OraQuick Advance HIV 1/2 Kit Controls — OraSure Technologies, Inc. · Class III
- VITROS — Ortho-Clinical Diagnostics · Class I
- VIROTROL — Bio-Rad Laboratories · Class II
- INSTI HIV-1/HIV-2 Control Test Kit — Biolytical Laboratories Inc · Class II
Cleared under the same submission
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
- Bio-Rad
Sources (1)
- FDA UDI 11277210-5d00-45fc-910f-b0aa9497c721 36 fields · synced May 30, 2026