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ELISA T. pallidum IgG Smart Kit Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA T. pallidum IgG Smart Kit Test System FDA UDI
Generic Name
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors. FDA UDI
Model / Reference
SM3Z7611G FDA UDI
Description
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors. FDA UDI

Identifiers

Catalog Number
SM3Z7611G FDA UDI
Primary DI / UDI-DI
00845533001168 FDA UDI
GMDN Term
Treponema pallidum immunoglobulin G (IgG) 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: Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA T. pallidum IgG Smart Kit Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 240cdde5-1da1-404a-853c-4a20bdd7c310 35 fields · synced May 30, 2026