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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
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI
Device Name
ANA Screen with MDSS Reagent pack FDA UDI
Model / Reference
6651150 FDA UDI
Description
ANA Screen with MDSS Reagent pack FDA UDI

Identifiers

Catalog Number
6651150 FDA UDI
Primary DI / UDI-DI
00847865000086 FDA UDI
FDA Product Code
LKO FDA UDI
MQA FDA UDI
LRM FDA UDI
LLL FDA UDI
LJM FDA UDI
LKJ FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 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

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: Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

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

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex.

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 c61eb2d3-e53c-47bc-87e9-93909b61702e 37 fields · synced May 30, 2026