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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 Coeliac disease-associated antibody IVD, kit, multiplex FDA UDI
Device Name
Celiac IgG Assay Protocol file CD, SW4_v1 FDA UDI
Model / Reference
SW4_v1 FDA UDI
Description
Celiac IgG Assay Protocol file CD, SW4_v1 FDA UDI

Identifiers

Catalog Number
6652270A FDA UDI
Primary DI / UDI-DI
00847865010573 FDA UDI
FDA Product Code
MVM FDA UDI
MST FDA UDI
GMDN Term
Multiple Coeliac disease-associated antibody IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
866.5750 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: Multiple Coeliac disease-associated antibody 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 Coeliac disease-associated antibody 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 2784e32c-3a93-4be0-b2a0-5d9ec8468de8 36 fields · synced May 30, 2026