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Home / RealStar® SARS-CoV-2 RT-PCR Kit 1.0 receives ANVISA approval

RealStar® SARS-CoV-2 RT-PCR Kit 1.0 receives ANVISA approval

14th of May 2020

RealStar® SARS-CoV-2 RT-PCR Kit 1.0 approved by ANVISA (Reg. No. 80102512482)

altona Diagnostics Brasil LTDA, São Paulo, the brazilian subsidiary of altona Diagnostics GmbH, Germany, specialized in infectious diseases, obtained today, 14th of May 2020, the approval of the registration at ANVISA, the Brazilian Health Authority, for its real-time PCR kit to detect the RNA of SARS-CoV-2, causative agent of COVID-19.

Before the approval of ANVISA, the RealStar® SARS-CoV-2 RT-PCR Kit 1.0 has among others also obtained the Emergency Use Authorization of FDA, USA, and the approval in the European Union.


RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is a real-time PCR test ready to use, which detects the lineage B betacoronavirus and specifically SARS-CoV-2. The kit forms part of the broad portfolio of tests of altona for infectious diseases including kits for tropical and emerging diseases, infections in immunosuppressed patients, infections caused by virus transmitted by blood transfusion, and viral and bacterial infections causing respiratory and enteric diseases.


Following the strategy of open platform, the PCR kit could be used on a variety of real-time PCR thermocyclers, frequently used in diagnostic laboratories.

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Please find a portugues version as PDF download.