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AtheNA Multi-Lyte® T. pallidum IgG Plus Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
AtheNA Multi-Lyte® T. pallidum IgG Plus Test System FDA UDI
Generic Name
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors. FDA UDI
Model / Reference
A76101G FDA UDI
Description
The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. 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
A76101G FDA UDI
Primary DI / UDI-DI
00845533000116 FDA UDI
GMDN Term
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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, fluorescent immunoassay

AtheNA Multi-Lyte® T. pallidum IgG Plus 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, fluorescent immunoassay.

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 4edfcf6d-b965-46a2-b4fd-e5b331662256 35 fields · synced May 30, 2026