Article: Company files for IDE for rapid HIV test.(Epitope Inc.)(Brief Article)

Article: Company files for IDE for rapid HIV ...
Medical Laboratory Observer;  July 1, 2000 ;     529 words ...Epitope, Inc. (Beaverton, OR), which markets the OraQuick rapid oral-fluid or blood test for HIV, has filed for an investigational device exemption for the test with the FDA. The assay, which can provide results with 20 minutes and has been shown in trials to have a sensitivity and specificity of

Article: Company files additional data with FDA on new ...
Biotech Week;  January 14, 2004 ;     597 words ... ... the same time, the company had pursued an additional application for this product. The new version of the approved rapid HIV test includes an on-board procedural and reagent control line, which potentially eliminates the need for external controls ...

Article: Most HIV test kits in China domestically made - ...
China Business News;  December 3, 2008 ;     539 words ...Most HIV test kits in China domestically made - expert ... December 3. INTERFAX-CHINA - Most HIV test kits in China are produced by domestic ... discrepancies between domestically- produced HIV test kits and imported test kits," Wang Youchun ...

Article: ChemTrak files for FDA approval of home access HIV ...
Business Wire;  February 8, 1995 ;     700+ words ... ... application for the ChemTrak home access HIV test with the Food and Drug Administration ... self-test, the ChemTrak home access HIV test includes testing as well as counseling ... founder of ChemTrak's home access HIV test business. "Treatment advances can help ...

Article: ChemTrak reports new AWARE Rapid HIV Test meets ...
Business Wire;  June 4, 1997 ;     700+ words ... ... clinical trials of one-step AWARE(TM) Rapid HIV Test (Rapid HIV Test) with results equivalent to the gold standard ELISA ... The significant differentiating factor: Rapid HIV Test brings accurate HIV test results in three to fifteen ...

Article: ChemTrak(R) Reports New Aware(TM) Rapid HIV Test ...
PR Newswire;  June 3, 1997 ;     700+ words ... ... pre-clinical trials of the one-step AWARE Rapid HIV Test (Rapid HIV Test) with results equivalent to the gold standard Western ... The significant differentiating factor: Rapid HIV Test brings accurate HIV results in three to fifteen minutes ...

Article: MedMira Presents World's First OTC Rapid HIV Test ...
PR Newswire;  March 2, 2005 ;     700+ words ...MiraCare(TM) Rapid HIV Test Shows 100% Agreement in Independent ... evaluation of the MiraCare(TM) Rapid HIV Test which showed 100% agreement with traditional ... blood. "Our MiraCare(TM) Rapid HIV Test is one of the newest and greatest developments ...