Identity
- Trade Name
- VIROTROL FDA UDI
- Generic Name
- Treponema pallidum total antibody IVD, control FDA UDI
- Device Name
- VIROTROL Syphilis LR-B (An unassayed (human) serology control.) FDA UDI
- Model / Reference
- 00172X FDA UDI
- Description
- VIROTROL Syphilis LR-B (An unassayed (human) serology control.) FDA UDI
Identifiers
- Catalog Number
- 00172X FDA UDI
- Primary DI / UDI-DI
- 00847661005452 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Treponema pallidum total 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treponema pallidum total antibody IVD, control
Virotrol by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treponema pallidum total antibody IVD, control.
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- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- LIAISON® Treponema Serum Controls — Diasorin Inc.
- MAS Syphilis Positive Control — Microgenics Corporation · Class I
- ARCHITECT — Abbott · Class II
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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 4ab137d2-59e8-4282-90b4-8f749d2a011e 36 fields · synced Jun 8, 2026