WebFilmArray BioThreat-E Kit Detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood and urine specimens. Authorized by the US FDA: Oct. 25, 2014 For Use Under the Emergency Use Authorization (EUA) by CLIA Moderate and High Complexity Laboratories. • This test has not been FDA cleared or approved; WebThe Anthrax BioThreat Alert® Kit aids in the detection of anthrax. It is intended for use with the BioThreat Alert® Flex Reader. A 25-strip box includes materials for collection of five samples. Extra material can be …
What does biothreat mean? - Definitions.net
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Biothreat Detection │ Biological Aerosol Collection & Identification
WebJan 20, 2012 · These assays are packaged and freeze-dried in ITI’s patented pouch system that is designed specifically to run on the RAZOR™ BioThreat Detection System platform. In addition to testing for 10 biothreat targets, the RAZOR CRP BioThreat-X Kit includes a PCR inhibition control and amplification control that confirms proper system operation. WebTrade/Device Name: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel Regulation Number: 21 CFR 866.4000 Regulation Name: Device To Detect And Identify Biothreat Microbial Agents In Human Clinical Specimens. Regulatory Class: Class II Product Code: QVR, QMV, PMN WebFor the BioThreat Alert ® test strips, the presence of contaminants is indicated by the appearance of a colored line within 15 minutes of the application of a water sample. The … eagle ridge middle school rating