07:00 , Apr 6, 2015 |  BC Week In Review  |  Clinical News

AmpliVue Trichomonas Assay regulatory update

FDA granted 510(k) clearance for Quidel’s AmpliVue Trichomonas Assay to diagnose trichomoniasis from vaginal swabs from symptomatic or asymptomatic female patients. The product detects nucleic acids from Trichomonas vaginalis and is now available in the...
08:00 , Jan 26, 2015 |  BC Week In Review  |  Clinical News

AmpliVue Bordetella Assay regulatory update

FDA granted 510(k) clearance to Quidel’s AmpliVue Bordetella Assay to detect Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients with respiratory tract infection. Quidel said the product is now available in...
07:00 , Aug 11, 2014 |  BC Week In Review  |  Clinical News

AmpliVue GAS Assay regulatory update

FDA granted 510(k) clearance to Quidel’s AmpliVue GAS Assay to qualitatively detect Group A beta-hemolytic Streptococcus pyogenes nucleic acids isolated from throat swab specimens from patients with signs and symptoms of pharyngitis. The hand-held assay...
07:00 , Apr 7, 2014 |  BC Week In Review  |  Clinical News

AmpliVue HSV 1+2 Assay regulatory update

Quidel said FDA granted 510(k) clearance for AmpliVue HSV 1+2 Assay to detect and differentiate herpes simplex virus type 1 (HSV-1) and HSV-2. The hand-held test uses isothermal Helicase Dependent Amplification (HDA) and lateral flow...
08:00 , Jan 13, 2014 |  BC Week In Review  |  Clinical News

AmpliVue Group B Strep Assay regulatory update

Late last month, Quidel said FDA granted 510(k) clearance for AmpliVue Group B Strep Assay to detect Group B Streptococcus from enriched broth cultures of specimens from antepartum women. The hand-held assay uses isothermal Helicase...
08:00 , Dec 24, 2012 |  BC Week In Review  |  Clinical News

AmpliVue regulatory update

Quidel said FDA granted 510(k) clearance for AmpliVue to detect toxigenic Clostridium difficile bacterial DNA. The product is now available in the U.S. and EU. The hand-held assay which detects C. difficile DNA using real-time...
07:00 , Apr 2, 2012 |  BC Week In Review  |  Clinical News

AmpliVue regulatory update

Quidel said it received CE Mark approval for AmpliVue to detect Clostridium difficile bacterial DNA. The hand-held assay detects C. difficile DNA using real-time PCR. The product is marketed in Europe. Quidel Corp. (NASDAQ:QDEL), San...