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

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Bio-Rad Laboratories Pty Ltd

Klasse:

Class 3

Produsert av:

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

Terapeutisk område:

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

Indikasjoner:

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.

Autorisasjon status:

A

Autorisasjon dato:

2013-05-07