← Back to catalogue

BioPlex 2200

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
BioPlex 2200 FDA UDI
Generic Name
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex FDA UDI
Device Name
U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1 FDA UDI
Model / Reference
12008626 FDA UDI
Description
U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1 FDA UDI

Identifiers

Catalog Number
12008626 FDA UDI
Primary DI / UDI-DI
03610522053131 FDA UDI
FDA Product Code
JIX FDA UDI
JJY FDA UDI
NHX FDA UDI
GMDN Term
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1660 FDA UDI
866.5775 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: Cyclic citrullinated peptide antibody (anti-CCP) 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 Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 79528d0c-e96e-481c-b724-8f0716a3084d 36 fields · synced May 29, 2026