ZEUS SCIENTIFIC, INC.

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

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Device Description : The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibo The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM antibodies to T. gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive T. gondii infection. To adquately assess the patient’s serological status; testing must be performed in conjunction with an anti-T. gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. Performance characteristics have not been established for screening sera from prenatal women or newborns.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitati The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA Cytomegalovirus (CMV) IgM Test System is designed for qualitative d The ZEUS IFA Cytomegalovirus (CMV) IgM Test System is designed for qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. The Test System is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA Herpes Simplex Virus-1 (HSV-1) IgG Test System is designed for the The ZEUS IFA Herpes Simplex Virus-1 (HSV-1) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (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 Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the The ZEUS IFA Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (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 Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System i The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is designed for the qualitative and semi-quantitative detection of EBV-VCA IgG antibodies in human serum 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 Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System i The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum 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 Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sens The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sens The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sens The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.

Device Class :

Duns Number: 080953946

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1