← 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
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0 FDA UDI
Model / Reference
4.3_v1.0 FDA UDI
Description
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0 FDA UDI

Identifiers

Catalog Number
12000883 FDA UDI
Primary DI / UDI-DI
03610520506462 FDA UDI
510(k) Number
K183446 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 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: Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K183446 also covers:

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 6e8dc141-d64c-4326-a6de-70dc0f0bea2c 37 fields · synced Jun 8, 2026