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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
Multiple Coeliac disease-associated antibody IVD, control FDA UDI
Device Name
Celiac IgG Control Set FDA UDI
Model / Reference
6632230 FDA UDI
Description
Celiac IgG Control Set FDA UDI

Identifiers

Catalog Number
6632230 FDA UDI
Primary DI / UDI-DI
00847865010627 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Multiple Coeliac disease-associated antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Dimensions & Sizes

Size
Total Volume — 1.5 Milliliter FDA UDI

Category: Multiple Coeliac disease-associated antibody IVD, control

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

Similar devices

Also classified as Multiple Coeliac disease-associated 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 fb0b5594-0879-4e50-895c-2ec344a1d1d3 37 fields · synced May 30, 2026