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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Becton Dickinson Pty Ltd

Classe:

Class 3

Prodotto da:

Becton Dickinson and Company 7 Loveton Circle, Sparks, Maryland, 21152 United States Of America

Area terapeutica:

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

Indicazioni terapeutiche:

The BD ProbeTec? Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper? System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The Control Set for the BD ProbeTec? Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays contains Positive and Negative Controls that are intended for Quality Control use with the BD ProbeTec? Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) when tested with the BD Viper? System in Extracted Mode.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2012-01-13