AtheNA Multi-Lyte® T. pallidum IgG Plus Test System
Primary DI
00845533000116
Brand
AtheNA Multi-Lyte® T. pallidum IgG Plus Test System
Company
ZEUS SCIENTIFIC, INC.
Model
A76101G
Catalog number
A76101G
Device 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.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.