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ImmunoDOT Leptospira IgM

FDA UDI

Class II (US FDA UDI)

by Genbio

Identity

Trade Name
ImmunoDOT Leptospira IgM FDA UDI
Generic Name
Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood. FDA UDI
Model / Reference
800-4034 FDA UDI
Description
The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood. FDA UDI

Identifiers

Catalog Number
4034 FDA UDI
Primary DI / UDI-DI
00613745000152 FDA UDI
510(k) Number
K002024 FDA UDI
FDA Product Code
GRY FDA UDI
GMDN Term
Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3350 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

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: Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoDOT Leptospira IgM by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K002024 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genbio

Sources (1)

  • FDA UDI c7d22e3d-e4e8-481a-9259-7aa695635f46 37 fields · synced May 30, 2026