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R-Biopharm receives approval of COVID-19 test in the UK under CTDA legislation

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Darmstadt, 7 December 2021 – R-Biopharm, an international specialist in clinical diagnostics, announces that the company’s RIDA®GENE Flu & SARS-CoV-2 multiplex test (PG6825) has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (“CTDA”). R-Biopharm will now work to resume the sale of the product in the UK.

RIDA®GENE Flu & SARS-CoV-2 test is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of Flu A/Flu B and coronavirus (SARS-CoV-2) RNA in human nasal/throat swabs from persons with signs and symptoms of respiratory infection. It is intended for professional use for example in hospital laboratories, reference laboratories, private laboratories, or public laboratories. The RIDA®GENE Flu & SARS-CoV-2 multiplex test targets the M gene/NP1 gene of the virus for Influenza A/B and the E gene and RdRpgene in all currently known variants and mutations of the COVID 19 virus.

Only validated products, or products on the temporary protocol, can be sold in the UK after 31 October 2021. Jason Baggaley, Sales Manager of R-Biopharm for Great Britain, commented: “We are proud that our RIDA®GENE Flu & SARS-CoV-2 test was approved and added to the CTDA register and our customers will continue to be able to distinguish between the flu and an infection with the Corona virus.“

 Press contact:

Simone Feiler
Head of Corporate Brand Communication
https://r-biopharm.com 
https://r-biopharm.com/news-press

R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany

Tel.: 0 61 51 - 81 02-538
Mobile: 0 160 - 55 273 60
Fax: 0 61 51 - 81 02-40

Email: s.feiler@r-biopharm.de 

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news aktuell, a subsidiary of the Deutsche Presse-Agentur (dpa), provides companies, institutions and associations with effective access to both the media and consumers and supports the organizations in telling their stories easily and successfully. Utilizing the digital tools “ots” and “zimpel” PR content reaches all media formats, including classic print titles, wide-reach online portals or social networks. In addition, news aktuell publishes all of its clients' PR content on www.presseportal.de, one of Germany's widest-reaching PR portals. Thus, all relevant multipliers are reached worldwide, ranging from editors and digital influencers to specialist bloggers and interested consumers. Communications specialists from all over Germany rely on the expertise of the dpa subsidiary. news aktuell has been on the market since 1989 and employs over 135 people. The company is based in Hamburg. Further locations include Berlin, Frankfurt and Munich.

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