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Device Description : The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosor The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosor The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosor The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosor The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detectio The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detectio The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detectio The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detectio The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-lin The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-lin The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes