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Device Description : The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunof The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Measles IgG Test System is designed for the qualitative and quantit The ZEUS IFA Measles IgG Test System is designed for the qualitative and quantitative detection of Measles antibody in human serum by the indirect fluorescent antibody (IFA) technique. The assay can determine or confirm recent infection or immune status and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The ZEUS IFA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qu The ZEUS IFA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative and semi-quantitative detection of VZ IgG antibody in human sera by the indirect fluorescent antibody (IFA) technique. The assay can determine or confirm a recent infection or immune status, and is for in vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualit The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualitative and semi-quantitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This Test System should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Legionella pneumophila Direct Fluorescent Antibody detection reagen The ZEUS IFA Legionella pneumophila Direct Fluorescent Antibody detection reagents are designed for the detection of Legionella (Groups 1 – 6) bacteria in various patient specimens, and are for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Legionella pneumophila (Group 1 - 6) Test System is an indirect flu The ZEUS IFA Legionella pneumophila (Group 1 - 6) Test System is an indirect fluorescent antibody (IFA) assay designed for the detection of L. pneumophila antibodies in human serum, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualita The ZEUS ANA HEp-2 Test System is a prestandardized kit 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
Prescription Use : Yes
Device Description : The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualita The ZEUS ANA HEp-2 Test System is a prestandardized kit 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
Prescription Use : Yes
Device Description : The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualita The ZEUS ANA HEp-2 Test System is a prestandardized kit 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
Prescription Use : Yes
Device Description : Zorba® IgG Removal Reagent is designed to functionally remove potentially interf Zorba® IgG Removal Reagent is designed to functionally remove potentially interfering immunoglobulin G (IgG) antibodies from human serum prior to testing for IgM. The product is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes