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BioPlex 2200

FDA UDI

Class I (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
BioPlex 2200 FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
EBV IgM Assay Protocol File CD, SW4.1_v1 FDA UDI
Model / Reference
SW4.1_V1 FDA UDI
Description
EBV IgM Assay Protocol File CD, SW4.1_v1 FDA UDI

Identifiers

Catalog Number
6651370D FDA UDI
Primary DI / UDI-DI
00847865001236 FDA UDI
FDA Product Code
LJN FDA UDI
KTN FDA UDI
GMDN Term
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3235 FDA UDI
866.5640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 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) 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 df9a9e46-c48c-4ab4-9c71-74df0f14d2b5 36 fields · synced May 30, 2026