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BioPlex 2200

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
BioPlex 2200 FDA UDI
Generic Name
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
MMRV IgG Control Lot Data FDA UDI
Model / Reference
6632440 FDA UDI
Description
MMRV IgG Control Lot Data FDA UDI

Identifiers

Catalog Number
6632440 FDA UDI
Primary DI / UDI-DI
00847865000758 FDA UDI
FDA Product Code
OPL FDA UDI
LJY FDA UDI
LFY FDA UDI
LJB FDA UDI
GMDN Term
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3510 FDA UDI
866.3380 FDA UDI
866.3900 FDA UDI
866.3520 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, controlRubella virus immunoglobulin G (IgG) antibody IVD, controlMeasles virus immunoglobulin G (IgG) antibody IVD, controlMumps virus immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Measles virus immunoglobulin G (IgG) 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 c5f56830-0a1d-4694-8e74-f56a4dedb6ae 36 fields · synced Jun 6, 2026