66 results
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26ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·May 23, 2018
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·May 23, 2018
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·August 22, 2018
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 26, 2018
Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·February 7, 2018
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·May 23, 2018
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·February 7, 2018
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
AIA-900 Analyzer, Product code 022930, 022930R
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·November 21, 2018
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·May 23, 2018
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·March 17, 2021
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·October 3, 2018
ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·March 7, 2018
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·June 13, 2018
ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·June 13, 2018