The website for professionals in Laboratory Medicine

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

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 CTDA Regulations 2021.

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 RdRp gene 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 Coronavirus Test Device Approvals (CTDA) register, and our customers will continue to be able to distinguish between the flu and an infection with the coronavirus.

https://r-biopharm.com/

Upcoming Events

Point of Care: Innovations

The Bristol - Harbourside (Doyle Collection) hotel
20 September 2022

Arab Lab Live 2022

Dubai International Convention & Exhibition Centre Dubai World Trade Centre - Trade Centre - Trade Centre 2 - Dubai - United Arab Emirates
24 - 26 October 2022

Lab Innovations 2022

Hall 2 NEC, Birmingham
2 & 3 November 2022

MEDICA 2022

Messe Düsseldorf D-40474 Düsseldorf, Stockumer Kirchstraße 61
14 - 17 November 2022

Meeting demand: the changing picture of diagnostics

The King's Fund, London, W1G 0AN
16 November 2022

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Upcoming Events

Point of Care: Innovations

The Bristol - Harbourside (Doyle Collection) hotel
20 September 2022

Arab Lab Live 2022

Dubai International Convention & Exhibition Centre Dubai World Trade Centre - Trade Centre - Trade Centre 2 - Dubai - United Arab Emirates
24 - 26 October 2022

Lab Innovations 2022

Hall 2 NEC, Birmingham
2 & 3 November 2022

MEDICA 2022

Messe Düsseldorf D-40474 Düsseldorf, Stockumer Kirchstraße 61
14 - 17 November 2022

Meeting demand: the changing picture of diagnostics

The King's Fund, London, W1G 0AN
16 November 2022

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999 Fax: 01892 616177
www.step-communications.com
© 2022 Step Communications Ltd. Registered in England. Registration Number 3893025