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Device Description : The ZEUS ELISA dsDNA Test System is a semi-quantitative immunoassay for the dete The ZEUS ELISA dsDNA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay 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 Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System pro The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System pro The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System pro The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is 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 Viral Capsid Antigen (EBV-VCA) IgM Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is 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 Viral Capsid Antigen (EBV-VCA) IgM Test System The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes