New registered sanitary certificates for RealStar® kits for BK virus, Human Herpesvirus 6A & 6B and Epstein-Barr virus in Argentina
Buenos Aires, 1st of October 2019.
altona Diagnostics Argentina S.R.L, in representation of its headquarter in Hamburg Germany, today has announced the registration of three real time PCR Kits at the local Argentinian Sanitary authority.
From altona Diagnostics´ broad IVD-CE marked product portfolio, the Argentinian branch has been recently get granted by the local Argentinian sanitary authority ANMAT obtaining the sanitary registration certificates for the real-time PCR Kits for the detection and quantification of BK virus, Human Herpesvirus 6A& 6B, and Epstein-Barr virus.
These kits detect and quantify in International Units the virus genetic material extracted from human samples, regarding the kit for HHV-6 this product can detect and differentiate its two subtypes.
The RealStar® altona Diagnostics kits contain the specific reagents directed to detect and quantify nucleic acids of the pathogen, as well as the necessary internal controls in order to detect inhibitions or unspecific interactions that may occur during its use.
The RealStar® PCR assays are ready to use kits and reagent systems which consist of master reagents containing enzyme, buffer, primer and probes as well as an internal control, PCR grade water and a positive control or quantification standards. These test systems were developed and validated for the use with various real-time PCR instruments.
altona Diagnostics GmbH is a Hamburg, Germany, based company dedicated to developing, and producing reagents to detect and quantify different kind of pathogens that cause human infectious diseases.
RealStar® HEV RT-PCR Kit 2.0 receives ANVISA approval (Registration Number: 80102512353)
São Paulo, Brazil, November 4th, 2019.
altona Diagnostics Brasil LTDA, São Paulo, the Brazilian subsidiary of the German infectious disease specialist altona Diagnostics GmbH (altona), Hamburg, got registration approval of ANVISA for its real-time PCR kit to detect and quantify hepatitis E virus specific RNA.
The RealStar® HEV RT-PCR Kit 2.0 is a ready-to-use, real-time PCR test that is part of altona's infectious disease testing portfolio, ranging from testing for tropical and emerging diseases, infections in immunosuppressed patients, infections caused by blood transfusion-transmission viruses and viral and bacterial infections causing respiratory and enteric diseases.
RealStar® kits para virus BK, Herpesvirus humano 6A y 6B y para virus Epstein-Barr se encuentran registrados en Argentina ante ANMATpdf
|Fecha de lanzamiento:||01.10.2019|
altona aprova seu registro na ANVISA para kit RealStar® HEV RT-PCR Kit 2.0pdf
|Data de lançamento:||05.11.2019|