Quidel has obtained the US Food and Drug Administration (FDA) approval for two infectious disease tests that run on Life Technologies' QuantStudioDx instrument. Life Technologies' QuantStudioDx instrument offers the advanced capabilities ...
Tags: Diagnostic Tests, Quidel
Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer. It is used ...
Tags: FDA Clearance, HCG Fluorescent
Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. The Sofia Analyzer and ...
Tags: Quidel, Fluorescent Immunoassay
Quidel Corporation, a US-based virology assays and molecular diagnostic systems provider has completed the acquisition of BioHelix Corporation. As per the terms of the deal, Quidel will pay $10m in cash to the shareholders of BioHelix and ...
US-based diagnostic testing solutions provider Quidel has gained CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in ...
Tags: CE Mark, Molecular Direct, diagnostic testing solutions
Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The ...
Tags: Quidel, Life Technologies, FDA Approval
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
Life Technologies has introduced a new real-time PCR based molecular diagnostic instrument for diagnostic use in the Europe. The Applied Biosystems QuantStudio Dx instrument, which is released with Quidel Molecular assay for C. difficile, ...
Tags: molecular diagnostic instrument, diagnostic instrument, real-time PCR
Quidel has gained CE mark for the Quidel Molecular Direct C difficile Tox A/B assay to detect toxigenic Clostridium difficile bacterial DNA. The Quidel Molecular Direct C difficile Tox A/B assay kits consist of an extraction-free, ...
Tags: Quidel, Quidel Molecular Direct C difficile Tox A/B assay kits, CE mark
Quidel has received FDA 510(k) clearance for its Quidel Molecular Influenza A+B assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. Quidel received FDA clearance in December 2011 to run its Quidel ...
Tags: Quidel, FDA 510(k)clearance, Quidel Molecular Influenza A+B assay