The AltoStar® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and mucocutaneous swab specimens. It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection.
AltoStar® alpha Herpesvirus PCR Kit 1.5
Order No
AS0081543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® alpha Herpesvirus PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
Intended use
The AltoStar® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and mucocutaneous swab specimens. It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection
Specifications
Key features
- Detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2)
and varicella-zoster virus (VZV) specific DNA - CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
