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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
Treponema pallidum immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
BioPlex 2200 Syphilis Total & RPR Control Lot Data FDA UDI
Model / Reference
12000654 FDA UDI
Description
BioPlex 2200 Syphilis Total & RPR Control Lot Data FDA UDI

Identifiers

Catalog Number
12000654 FDA UDI
Primary DI / UDI-DI
03610520653005 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Treponema pallidum immunoglobulin G (IgG) 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

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: Treponema pallidum immunoglobulin G (IgG) 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 Treponema pallidum immunoglobulin G (IgG) 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 39ec7017-2512-4122-a7f3-a9aa55d5641c 36 fields · synced Jun 1, 2026