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

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Disponibbli minn:

Becton Dickinson Pty Ltd

Klassi:

Class 3

Manifatturat minn:

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

Żona terapewtika:

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

Indikazzjonijiet terapewtiċi:

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.

L-istatus ta 'awtorizzazzjoni:

A

Data ta 'l-awtorizzazzjoni:

2012-01-13