Qiagen Gets FDA 510(k) Clearance for MDx System, C. Diff Assay | GenomeWeb

NEW YORK (GenomeWeb) — Qiagen has received 510(k) clearance from the US Food and Drug Administration for its QIAsymphony RGQ MDx system and Artus C. difficile QS-RGQ MDx kit, the company said Monday after the close of the market.

QIAsymphony RGQ MDx is a modular system for performing entire laboratory workflows. It comprises the QIASymphony SP for sample preparation, QIAsymphony AS for assay setup, and Rotor-Gene Q MDx real-time PCR detection system, which received FDA clearance in 2012.

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 Nucleic Acids Research this week: personal genome approach to RNA-seq read alignment, hematopoietic Systems Biology Repository, and more.

A man is using DNA evidence to argue that he is the rightful heir to the baronetcy of Stichill, the Guardian reports.

As part of an effort to get a diverse group of people to donate their DNA for research, some blood donors in the San Diego area will get their genomes sequenced, according to KPBS.

The comment period on the Department of Health and Human Services' proposal to alter the Common Rule has been extended.