Search Results

The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The S-Test Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of CHO, HDL, and TG concentrations in serum or heparin plasma based on a photometric test measuring the formation of reddish purple complexes in coupled enzymatic reactions.

The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.

The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.

The S-Test Creatinine Reagent is intended for the quantitative determination of Creatinine concentration in serum or heparin plasma using the S40 Clinical Analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Creatinine (CRE) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CRE in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment in a coupled enzymatic reaction.

ACE® Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (umol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A 1 c using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only. The umol HbA1c and total hemoglobin (THb) values generated are intended for use in the calculation of the HbA1c/THb ratio and cannot be used individually for diagnostic purposes. Hemoglobin A1c Calibrators are intended for use in the performance of both a multi-point calibration for hemoglobin A1c and a single-point calibration of total hemoglobin on the ACE® clinical chemistry system, for the quantitative determination of percent (%) hemoglobin A1c in whole blood. For in vitro diagnostic use only. Hemoglobin Alc Controls are intended to reliably monitor the accuracy and precision of quantitative determinations of hemoglobin A1c on the ACE® clinical chemistry system. For in vitro diagnostic use only,

ACE® Hemoglobin A1c (HbA1c) Reagent is provided as a single kit and consists of four bottles containing a hemoglobin denaturant, a total hemoglobin reagent, a HbAlc agglutinator reagent and a HbA1c antibody reagent. The ACE Hemoglobin Alc Calibrators are provided as a single kit and contain ready-to-use liquid calibrators, one of each of six levels. The ACE Hemoglobin A1c Controls are provided as a single kit and contain lyophilized controls with normal and elevated levels of HbA1c and a reconstitution fluid. The controls are prepared from human whole blood, which has been tested and found negative for antibody to Human Immunodeficiency Virus (anti-HIV) Types 1 and 2, antibody to Hepatitis C (anti-HCV) and for Hepatitis B Surface Antigen (HBsAg) by FDA recommended (approved/licensed) tests.