Identity
- Trade Name
- VIROTROL FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) FDA UDI
- Model / Reference
- 200300C FDA UDI
- Description
- VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) FDA UDI
Identifiers
- Catalog Number
- 200300C FDA UDI
- Primary DI / UDI-DI
- 03610522207862 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) 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: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, controlSARS-CoV-2 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 SARS-CoV-2 total antibody IVD, control.
- Audit MicroControls Linearity LQ Anti-SARS-CoV-2 S for Roche Systems — Aalto Scientific, Ltd.
- SARS CoV-2 Controls (SARS-CoV-2) — Randox Laboratories, Ltd. · Class I
- VITROS — Ortho-Clinical Diagnostics · N
- VITROS — Ortho-Clinical Diagnostics · N
- VIROTROL — Bio-Rad Laboratories · Class I
- VIROCLEAR — Bio-Rad Laboratories · Class I
- VIROTROL — Bio-Rad Laboratories · Class I
- VIROCLEAR — Bio-Rad Laboratories · 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 15827f77-5172-4d98-bc2c-be178f1ffdf0 36 fields · synced May 31, 2026