ADVIA Centaur Erythropoietin (EPO) Assay
Axis-Shield Diagnostics Limited
Axis-Shield Diagnostics Limited
PMN#
ADVIA Centaur Calcitonin (CALCT) Assay
Axis-Shield Diagnostics Limited
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, And ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
AXIS-SHIELD DIAGNOSTICS LIMITED
GUDID#
Alere NT-proBNP for Alinity Reagent Kit (200 Tests) - The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system.In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
2025-02-26
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA - The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments
2019-08-02
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA - The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
2016-09-01
Axis® Homocysteine EIA - The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-06-13
Axis-Shield Homocysteine Controls - The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma.
2016-07-01
Axis-Shield Active-B12 (Holotranscobalamin) EIA - The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
2016-09-02
3-Reagent Homocysteine Assay for SYNCHRON UniCel - The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-07-01
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit - The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-07-01
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit - The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-07-01
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit - The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-07-01
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent - The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
2016-07-01
Alere NT-proBNP for Alinity Control Kit - The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma.For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.
2025-02-27
Alere NT-proBNP for Alinity Calibrator Kit - The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma.For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.
2025-02-27