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The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings. The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes.

The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

Human Chorionic Gonadotropin (hCG) test system for the use in early detection of pregnancy.

For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum or using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.

The ADVIA Centaur HER-2/neu assay is a fully automated, two-site sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, TA-1 labeled with acridinium ester. The Fluorescein Conjugate Reagent is composed of the monoclonal mouse antibody, NB-3, labeled with fluorescein. The two monoclonal antibodies are specific for unique epitopes on the extracellular domain of HER-2/neu. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with Fluorescein Conjugate Reagent and Lite Reagent simultaneously for 5.5 minutes. After this incubation, the Solid Phase is added and the mixture is incubated for an additional 2.75 minutes. After this final incubation, the immuno-complex formed is washed. The measured chemiluminescence is directly proportional to the quantity of HER-2/neu antigen in the sample.

The Ascensia ""Glucofacts and the Ascensia WinGlucofacts Professional software are accessories to the AscensiaTM Blood Glucose monitoring systems. The Ascensia ""Glucofacts and the Ascensia """Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.

The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software consist of a CD, and a connecting cable. It is to be used with a compatible blood glucose meter and a Personal Computer (PC). The software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.

The Bayer ADVIA® IMS cPSA assay is an in vitro diagnostic device intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum. This assay is indicated for the measurement of serum complexed PSA as an aid in management (monitoring) of prostate cancer patients. Complexed PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Prostate Specific Antigen (PSA) is a secretory product of the epithelial cells of human prostatic tissue, whether normal, benign, or malignant. The tissue specificity of PSA makes it a sensitive and specific tumor marker as an aid in management (monitoring) prostate cancer patients and disease progression following surgery or other therapies. PSA in serum exists in several forms including free, uncomplexed PSA and PSA complexed to several protease inhibitors including a-2-macroglobulin, a-1antichymotrypsin (ACT), and a-1-antitrypsin. It should be noted that there are no existing commercial methods that can recognize PSA bound to α-2-macroglobulin. However, it has been demonstrated that the proportion of PSA complexed with ACT increases as a function of the total PSA concentration, and that the majority of immunoreactive PSA in cancer patients is in complex with ACT. The Bayer cPSA Assay uses a monoclonal antibody for capture which recognizes both free and complexed PSA, but which, when bound to free PSA, precludes the binding of other antibodies specific for the free form of PSA. The inclusion of a second, unlabelled monoclonal antibody which is specific for free PSA prevents the binding of free PSA in the cPSA assay and allows measurement of only PSA which is complexed with ACT. cPSA can be used as a single test alternative to free and total PSA in management of patients with CaP.

The ASCENSIA™ DEX®2 Blood Glucose Meter is used with ASCENSIA™AUTODISC™ Blood Glucose Test Strips GLUCOMETER® DEX® Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIA™ DEX®2 Diabetes Care System is an Over-The-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

The ASCENSIA™ DEX®2 Diabetes Care System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the Bayer ADVIA Centaur CA 125 II assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

The ADVIA Centaur CA 125 II assay is a fully automated, single step sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, OC125, specific for CA 125, labeled with acridinium ester and the monoclonal mouse antibody M11, specific for CA 125, labeled with fluorescein. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with both Lite Reagent and Solid Phase simultaneously for 40 minutes. After incubation, the immuno-complex is washed. The measured chemiluminescence is directly proportional to the quantity of CA 15-3 antigen in the sample.

The CLINITEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. The CLINITEK ATLAS PRO Reagent Pak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.

The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive 12th pad that is used for the determination of the specimen color.

For the quantitative determination of alpha-fetoprotein (AFP) in the following: human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.

The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.

This in vitro immunoassay is intended to quantitatively measure CEA in human serum using ADVIA IMS CEA Assay on a Bayer ADVIA® IMS™. Carcinoembryonic Antigen (CEA) is a protein polysaccharide normally present at very low concentrations in the blood of healthy adults. Colorectal cancer and a variety of neonlantic and other disease processes cause significant elevation of CEA, thus issued as a tumor marker. CEA assay is designed to aid in the management and prognosis of cancer patients in whom changing concentrations of CEA are observed. The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to qualitatively measure carcinoembryonic antigen (CEA) in human serum. CEA test results are to be used as an aid in the management of cancer patients by monitoring CEA concentrations. CEA testing is not recommended as a screening procedure to detect cancer in the general population.

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