Downloads

Product Inserts, CLSI & MSDS

Select one of the products below to download the appropriate documents.




AtheNA Multi-Lyte® Test System


Infectious
Borrelia VlsE-1 IgG/pepC10 IgM Plus Test System

The ZEUS AtheNA Multi-Lyte® Borrelia VlsE1/pepC10 IgM Plus Test System is a multiplexed sandwich assay for the qualitative detection of IgG class antibody to recombinant VlsE1 and the IgM class of antibody to synthetic pepC10 in human serum. The AtheNA Multi-Lyte® Borrelia VlsE1/pepC10 IgM Plus Test System is intended for use in testing human serum samples which have been found equivocal or positive by alternate serological procedures to provide supportive evidence of infection by Borrelia burgdorferi. This kit is for in vitro diagnostic use only. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.


Product code: A90151

EBV IgM Plus Test System

The ZEUS AtheNA Multi-Lyte® EBV VCA IgM Plus Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. This test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus.


Product code: A92101M

EBV IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® EBV IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte® System. This test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus.


Product code: A92101G

HSV-1&2 IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® HSV 1 & 2 IgG Plus Test System is intended for the qualitative detection of the presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. This test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2.


Product code: A97101G

MMRV IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® MMRV Test System is intended for the qualitative detection of IgG class antibody to Measles, Mumps, Rubella, and Varicella-Zoster in human serum simultaneously in a single well. The AtheNA Multi-Lyte® MMRV Test System has the capability to report results separately and/or simultaneously and allows for additional results to be obtained well after the sample is discarded by analyzing data stored within the system.


Product code: A93101G

MMV IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® MMV Test System is intended for the qualitative detection of IgG class antibody to Measles, Mumps, and Varicella-Zoster in human serum simultaneously in a single well. The AtheNA Multi-Lyte® MMV Test System has the capability to report results separately and/or simultaneously and allows for additional results to be obtained well after the sample is discarded by analyzing data stored within the system.


Product code: A93111G

T. pallidum IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® T. pallidum IgG Plus Test System is intended for the qualitative detection of the IgG class of antibodies to Treponema pallidum in human serum. This test system is intended for use as an aid in the diagnosis of syphilis and/or to provide epidemiological information on said disease. This test system is for in vitro diagnostic use.


Product code: A76101G

ToRCH IgG Plus Test System

The ZEUS AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of IgG class antibodies to Toxoplasmosis gondii, Rubella, Cytomegalovirus and Herpes Simplex 1 and 2 viruses in human serum. The test system is intended to be used as an aid in the diagnosis of diseases caused by the exposure to Toxoplasmosis, Rubella, Cytomegalovirus and Herpes Simplex 1 and 2 and/or to provide epidemiological information on the associated disease. These tests are for in vitro diagnostic use only.


Product code: A81101G



Autoimmune
ANA II Plus Test System

The ZEUS AtheNA Multi-Lyte® ANA II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. This test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test system is for in vitro diagnostic use.


Product code: A21101

ANA III Plus Test System

The ZEUS AtheNA Multi-Lyte® ANA III Plus Test System is intended for the semi-quantitative detection of IgG class antibody to 9 separate analytes (SSA-52, SSA-60, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Ribosomal P) in human serum and the quantitative detection of IgG antibody to dsDNA in human serum. This test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test system is for in vitro diagnostic use.


Product code: A22001

Autoimmune Vasculitis Plus Test System

The ZEUS AtheNA Multi-Lyte® Autoimmune Vasculitis Plus Test System is intended for the qualitative and semi-quantitative detection of IgG class antibody to 3 separate Antigens (Glomerular Basement Membrane, Myeloperoxidase and Proteinase 3) in human serum. This test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of selected autoantibodies. MPO and/or PR3 may be associated with autoimmune disorders such as Wegener’s Granulomatosis, ICGN, MPA and PRS. Anti-Glomerular Basement Membrane (GBM) antibodies aid in the diagnosis of Goodpasture’s syndrome. These tests are for in vitro diagnostic use only.


Product code: A96101

RF IgM Plus Test System

The ZEUS AtheNA Multi-Lyte® RF Plus Test System is intended for the qualitative and/or quantitative detection of RF IgM class antibody. This test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. This test system is for in vitro diagnostic use.


Product code: A91101M

TPO/Tg Plus Test System

The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens (Thyroid Peroxidase (TPO) and Thyroglobulin (Tg) in human serum. This test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test system is in vitro diagnostic use only.


Product code: A51101