Address:LUNA PLACE,DUNDEE Scotland,GB
Device Description : The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked i 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.
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative 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.
Device Class : 1
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed qu 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.
Device Class : 1
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay ( 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.
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for 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.
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : No
Device Description : The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan 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.
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan 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.
Device Class :
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan 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.
Device Class :
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan 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.
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : No
Device Description : The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked i 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
Device Class : 2
Duns Number: 229062427
Premarket Exempt : No
Prescription Use : Yes