FAQ-1372
Are artus® kits legally authorized?
Since May 2002 artus has produced and inspected its products in accordance with the European guidelines (directives, standards) for in vitro diagnostics (directive 98/79/EG IVD).
Thus, they are allowed to carry the CE-label (directive 93/42/EWG MPG). A prerequisite for this is the maintenance of a certified quality management system according to DIN EN ISO 9001 as well as a running quality and conformation control for each lot produced.
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artus HCV PCR Kits
The artus HCV RG RT-PCR Kit and versions 1 and 2 of the artus HCV QS-RGQ Kit are ready-to-use molecular detection kits for real-time RT-PCR on Rotor-Gene instruments. The kits provide all necessary reagents optimized for reliable HCV RNA quantitation for in vitro diagnostic use. The artus HCV RG RT-PCR Kit uses manual sample preparation and assay setup techniques. The artus HCV QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup. The version 2 kit has been updated to meet the 2018 recommendations from EASL (1).References1. European Association for Study of the Liver (2018). EASL recommendations on treatment of Hepatitis C 2018. J. Hepatol., 69, 461
artus BK Virus PCR Kits CE
The artus BK Virus RG PCR Kit and the artus BK Virus QS-RGQ Kit are ready-to-use molecular detection kits for real-time PCR on Rotor-Gene instruments. The kits provide all necessary reagents optimized for rapid and sensitive detection of BK virus specific DNA with highly accurate quantitation of viral load for in vitro diagnostic use. The artus BK Virus RG RT-PCR Kit uses automated sample preparation and manual assay setup techniques. The artus BK Virus QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.
artus HI Virus-1 RT-PCR Kits CE
The artus HI Virus-1 RG RT-PCR Kit and the artus HI Virus-1 QS-RGQ Kit are ready-to-use molecular detection kits for real-time RT-PCR on Rotor-Gene Q instruments. The kits provide all necessary reagents optimized for reliable HIV-1 RNA detection and quantitation for in vitro diagnostic use. The artus HI Virus-1 RG RT-PCR Kit uses manual sample preparation and assay setup techniques. The artus HI Virus-1 QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.
artus VZV PCR Kits CE
artus VZV PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable VZV DNA detection and quantitation for in vitro diagnostic use. artus VZV LC, RG, and TM PCR Kits use manual or automated sample preparation and manual assay setup techniques. The artus VZV RG PCR Kit is also available as EASYartus VZV RG PCR Kits, which include the EZ1 DSP Virus Kit for automated viral nucleic acid purification. The artus VZV QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.
artus Parvo B19 PCR Kits CE
artus Parvo B19 PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable parvovirus B19 DNA detection and quantitation for in vitro diagnostic use.
artus M. tuberculosis PCR Kits CE
artus M. tuberculosis PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable detection and quantitation of DNA from all members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, and M. pinnipedii) for in vitro diagnostic use.
artus HSV-1/2 PCR Kits CE
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artus HBV PCR Kits CE
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artus EBV PCR Kits CE
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artus CMV PCR Kits CE
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