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Virotrol

FDA UDI

Class I (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
VIROTROL FDA UDI
Generic Name
Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control FDA UDI
Device Name
VIROTROL EBV (An unassayed (human) serology control.) FDA UDI
Model / Reference
00128B FDA UDI
Description
VIROTROL EBV (An unassayed (human) serology control.) FDA UDI

Identifiers

Catalog Number
00128B FDA UDI
Primary DI / UDI-DI
00847661005575 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) 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: Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, controlEpstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) 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 Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 02073cfe-0a35-4b01-91f5-6249feb5e63f 36 fields · synced May 30, 2026