FDA Clears Two Quidel Respiratory Infection Assays on Life Tech Platform | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx Real-Time PCR instrument, the companies said today.

The Quidel Molecular Influenza A+B assay detects influenza A and/or B virus, but does not differentiate influenza A subtypes. However, the assay is able to detect subtype H7N9, which has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In Science this week: new chromatin imaging approach, and more.

University of Wisconsin researchers uncover a mutation linked to Mauriac syndrome, which affects some children with type 1 diabetes.

Theranos has hired executives to oversee compliance and regulatory issues, the Wall Street Journal reports.

Chinese researchers to embark on a trial using a CRISPR/Cas9-based immunotherapy next month, Nature News reports.