The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile. The GenomEra C. difficile assay, which is designed for use with the company's ...
IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system. The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and ...
Tags: IntelligentMDx, HSV-1/2 test, Abbott m2000 system, HSV
Rheonix, a developer of molecular diagnostic platforms, will present data of its automated KRAS CARD molecular diagnostic assay. The KRAS CARD is designed to detect seven known somatic mutations of KRAS oncogene from either fresh or ...
Tags: Rheonix, KRAS CARD, diagnostic assay, KRAS assay