7 results
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31ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·August 22, 2018
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·April 17, 2013
AIA-PACK TPOAb CONTROL SET
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·June 7, 2017
AIA-PACK TgAb CONTROL SET
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·June 7, 2017
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·July 22, 2015
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·August 3, 2016
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·December 19, 2018