15 results
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14ms
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Sources: EU EUDAMED, US FDA
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 2019
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 22, 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
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 C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Enforcement
Class III
·Terminated·Abbott Laboratories·May 13, 2020
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
FDA Enforcement
Class III
·Ongoing·Abbott Laboratories·January 25, 2023