Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

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11-11-2017

Fáanlegur frá:

Bio-Rad Laboratories Pty Ltd

Tegund:

Class 3

Framleitt af:

Bio-Rad Laboratories Inc 4000 Alfred Nobel Drive, Hercules, California, 94547 United States Of America

Lækningarsvæði:

CT749 - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Ábendingar:

A multiplex flow immunoassay intended for the qualitative detection of and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population?s prevalence and the pretest likelihood of HSV-1nd HSV-2.

Leyfisstaða:

A

Leyfisdagur:

2013-05-07

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