2 results
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8ms
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Sources: EU EUDAMED, US FDA
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·July 31, 2019
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·July 31, 2019