5 results
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6ms
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Sources: EU EUDAMED, US FDA
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·July 2, 2014
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
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
FDA Enforcement
Class III
·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016