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 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.