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Device Description : The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provide The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provide The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provide The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA ENA Profile-6 Test System is a semi-quantitative immunoassay for The ZEUS ELISA ENA Profile-6 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi- The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi- The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Gliadin IgG Test System is intended for the qualitative and semi- The ZEUS ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Gliadin IgG Test System is intended for the qualitative and semi- The ZEUS ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes