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

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Beschikbaar vanaf:

Becton Dickinson Pty Ltd

klasse:

Class 3

Geproduceerd door:

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

Therapeutisch gebied:

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

therapeutische indicaties:

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.

Autorisatie-status:

A

Autorisatie datum:

2012-01-13