Identity
- Trade Name
- VIROTROL FDA UDI
- Generic Name
- HIV1 antigen IVD, control FDA UDI
- Device Name
- VIROTROL HIV-1 Ag (An unassayed (human) serological control.) FDA UDI
- Model / Reference
- 00108A FDA UDI
- Description
- VIROTROL HIV-1 Ag (An unassayed (human) serological control.) FDA UDI
Identifiers
- Catalog Number
- 00108A FDA UDI
- Primary DI / UDI-DI
- 00847661004998 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- HIV1 antigen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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
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 antigen IVD, control
Virotrol by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1 antigen IVD, control.
- VITROS — Ortho-Clinical Diagnostics · Class I
- VIROTROL — Bio-Rad Laboratories · Class II
Cleared under the same submission
BK930033 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI fc203ed8-6ce9-4a28-9598-80ac1239c429 37 fields · synced May 30, 2026