ZEUS SCIENTIFIC, INC.

Address:200 EVANS WAY,BRANCHBURG,NJ,08876,US

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Device Description : The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody in human sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA nDNA Test System is a pre-standardized assay designed for the quali The ZEUS IFA nDNA Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibodies to native DNA by the Indirect Fluorescent Antibody (IFA) technique and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA Rat Liver Tissue Test System is designed for the qualitative an The ZEUS IFA ANA Rat Liver Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA Mouse Kidney Tissue Test System is designed for the qualitative The ZEUS IFA ANA Mouse Kidney Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

- Catalog Number : FA3001

Device Description : The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the q The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative and semi-quantitative detection of Mitochondrial Antibodies (MA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1