← Back to catalogue

ELISA B. burgdorferi IgM Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA B. burgdorferi IgM Test System FDA UDI
Generic Name
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human sera. This Test System should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western Blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. FDA UDI
Model / Reference
3Z9651M FDA UDI
Description
The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human sera. This Test System should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western Blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. FDA UDI

Identifiers

Catalog Number
3Z9651M FDA UDI
Primary DI / UDI-DI
00845533000192 FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

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

No

FDA UDI

Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

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
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI cccc6941-1ef3-44ac-a19b-cf6f3f399744 35 fields · synced May 30, 2026