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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
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI
Device Name
BioPlex 2200 Lyme Total Control Set FDA UDI
Model / Reference
12000879 FDA UDI
Description
BioPlex 2200 Lyme Total Control Set FDA UDI

Identifiers

Catalog Number
12000879 FDA UDI
Primary DI / UDI-DI
03610520506424 FDA UDI
510(k) Number
K183446 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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

Yes

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: Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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 Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control.

Cleared under the same submission

K183446 also covers:

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 d32e3418-e92a-4499-aa09-7aaaf8074455 38 fields · synced May 30, 2026