in-vitro-diagnostic-use Downloads
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Entire CE-IVD product range for in vitro diagnostic ...
Magnosphere™ are magnetic microparticles which can be used for life science research and in vitro diagnostic use. Available are two different type of surface characteristics; hydrophilic (MS) and hydrophobic (MX), and both chemically-functionalized products and bio-functionalized ...
The Novodiax ihc DAB 1:1 Kit is intended for in vitro diagnostic use. The kit can also be used with the Novodiax ihcDirect® in vitro diagnostic tests and other immunohistochemistry (IHC) test applications to form visible brown color during IHC test procedures. The ihc DAB 1:1 reagents arrive liquid, ready-to-use bottles with color coded pour-off dispense lids. Users prepare the ihc DAB 1:1 ...
METAglut1™ is an in Vitro Diagnostic Medical Device used to aid in the diagnosis of the GLUT1 Deficiency Syndrome (GLUT1DS). It is a regulated health product that bears the CE mark. The first test for the daily practice developed from the METAdiag platform. ...
Mispa Count X Plus is a quantitative Auto Hematology Analyzer and 3-part differential counter for in Vitro Diagnostic Use in clinical laboratories. The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results. ...
The DRG Aldosterone ELISA is a manual enzyme immunoassay for the quantitative measurement of aldosterone in human serum or plasma (EDTA, Li-heparin or citrate plasma) or urine. For in vitro diagnostic use. For laboratory professional use. The device is intended to be used as an aid to diagnosis of primary and secondary aldosteronism. The device is not intended for the diagnosis of adenomas. ...
The CardioChek test system (consisting of the CardioChek analyzer and PTS Panels self-test strips) is for the measurement of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended for self-testing use. This system should only be used with single-use, auto-disabling lancing devices. This system is for in ...
The Trinity Biotech Captia Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity ...
The Trinity Biotech Captia Herpes Group IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of ...
The Trinity Biotech Captia Borrelia burgdorferi (B. burgdorferi) IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be ...
The MDT2 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertips, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an ...
The EASYMAX® Voice Self-Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood and venous blood from fingertip, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, ...
The EASYMAX® MU Self-Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood and venous blood from fingertip, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as ...
The EASYMAX® sugarwatch Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh venous blood or capillary whole blood from fingertip, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare ...
The EASYMAX® Tag Self-Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh venous blood or capillary whole blood from fingertip, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as ...
The EASYMAX® SMBG System is intended for the quantitative measurement of glucose in fresh venous blood and capillary whole blood samples drawn from the fingertip, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of ...
The EASYMAX® BT Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh venous blood and capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as ...
The EASYMAX® T1 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh venous blood and capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as ...
The IVD CAPSULE PSP is a rapid, single-use in vitro diagnostic test for the determination of Pancreatic Stone Protein (PSP) in blood for the calculation of the cSOFA score at the point of care. The cSOFA score is used to assess the severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in ...
The IVD CAPSULE Ferritin is a rapid, single-use in vitro diagnostic test for the quantitative measurement of ferritin in capillary and venous whole blood, to aid blood diagnostic testing for iron deficiency in ...