CACLP - The largest IVD Expo & Conference

DiaSorin Molecular Receives CE Mark for Multiplex COVID-19, Influenza Test

Industry news | 22 September, 2021 | CACLP


Original from: Genomeweb

Image Credit: DiaSorin Official


DiaSorin Molecular announced on Monday that its Simplexa COVID-19 & Flu A/B Direct test has received CE marking. 


The multiplex test is designed for use on the Liaison MDX instrument and differentiates between SARS-CoV-2 and influenza A/B nucleic acids from one sample in one reaction well. 


It was validated with more than 80 strains of influenza, as well as emerging SARS-CoV-2 variants, said Cypress, California-based DiaSorin Molecular, which is part of Saluggia, Italy-based DiaSorin Group.


The test is run directly from nasopharyngeal swabs without needing off-board extraction and will be submitted to the US Food and Drug Administration for 510(k) review, the firm said.


DiaSorin received Emergency Use Authorization from the FDA in March 2020 for its Simplexa COVID-19 Direct test and FDA clearance for its Simplexa Flu A/B and RSV Direct Gen II kit in September 2020, which can be used with the COVID-19 test.


Source: DiaSorin Molecular Receives CE Mark for Multiplex COVID-19, Influenza Test

Filed under:
Press contact CACLP - The largest IVD Expo & Conference

Stay in touch with CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News, sign-up for our newsletter today.

  • Name *
  • Email *
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By subscribing our newsletter, you agree to our Privacy Policy. You can unsubscribe at anytime.

Share
Opening Countdown
0 0 0

Day(s)

0 0

Hour(s)

0 0

Min(s)

Room 2201-2203 & 2205, Cloud Nine Plaza
1118 West Yan’an Road
Shanghai, China
200052

Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )

We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy & Cookies for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

CACLP - The largest IVD Expo & Conference