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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
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
BioPlex 2200 ToRC IgM Reagent Pack FDA UDI
Model / Reference
12000670 FDA UDI
Description
BioPlex 2200 ToRC IgM Reagent Pack FDA UDI

Identifiers

Catalog Number
12000670 FDA UDI
Primary DI / UDI-DI
03610520992715 FDA UDI
FDA Product Code
LGD FDA UDI
LKQ FDA UDI
LFZ FDA UDI
PUQ FDA UDI
GMDN Term
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3780 FDA UDI
866.3175 FDA UDI
866.3510 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay.

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 2e63181d-27f8-4a2b-b100-dd30974971fb 37 fields · synced May 30, 2026