FDA Clears Quidel's Solana MDx Platform, Group A Strep Assay
Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology.
FDA Clears Quidel's MDx for Bordetella Pertussis
The clearance is the fourth for a Quidel test on the AmpliVue handheld MDx format.
FDA Clears Quidel's Amplivue Group A Strep Test
NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.
Quidel said last week that it has received 510(k) clearance from the US Food and Drug Administration for its AmpliVue HSV 1+2 assay for the differentiation of herpes simplex viruses 1 and 2.
Packaging isothermal PCR reagents in blisters and using lateral flow detection, researchers at Boston University hope to develop a low-cost, disposable assay for Bordetella pertussis, the causative agent of whooping cough.
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