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Instant View® Troponin I Test now available in the U.S. Troponin I (TnI) Whole Blood/Serum One Step Rapid Test This FDA 510k cleared and CE marked rapid immunoassay is intended for professional use as an aid in the diagnosis of Myocardial Infarction at emergency rooms, hospital settings or point-of-care facilities. The sensitivity of the test is 1.5 ng/ml for free cTnI and 5 ng/ml for complex cTnI. Its accuracy is 96.7%. It takes four drops of specimen, human whole blood or serum, to run the test. No additional reagents are required.  Instant View® H. Pylori Whole Blood Test is now CLIA waived H. Pylori Whole Blood One Step Rapid Test This FDA 510K cleared, CLIA waived, and CE marked test is a rapid qualitative immunoassay intended to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human whole blood. The sensitivity of this device is 95.1% and the specificity is 94.1%. The results can be read from 4 to 7 minutes. Quality. Service. Commitment. |
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