Cepheid Receives FDA Clearance For Xpert(R) HemosIL(R) FII & FV Test
Main Category: Vascular Also Included In: Medical Devices / Diagnostics ; Blood / Hematology ; Regulatory Affairs / Drug Approvals Article Date: 25 Sep 2009 - 2:00 PDT Cepheid and Instrumentation Laboratory announced that Cepheid has received clearance from the U.S. Food & Drug Administration to market its Xpert HemosIL FII & FV test.
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#1 Sep 28, 2009
This company, Cepheid, also makes a 50 minute MRSA test, cDiff, wound assay, blood culture bottle. Sensitivity and specificity are world class.
The company also had accomplished over 3 million tests with the USPS with no false positives.
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