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The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only. The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only. The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only. The performance of this device has not been established in neonate and pediatric patient populations.

Diazyme Fibrinogen Assay System consists of the following items: - 1. The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide. - 2. Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide - 3. Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide. The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals. The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths. After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-point calibration curve.

The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.

The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.

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