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The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / requires brand name or equal ST Genesia (model number: 86938) to support global hemostasis test to pr... The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / requires brand name or equal ST Genesia (model number: 86938) to support global hemostasis test to provide an evaluation of the coagulation potential of a plasma sample. The ST Genesia instrument will be responsible for about 90% of the total load of our lab. This instrument will use normalization, common calibration for all samples and corrective algorithms before final result is reported. The extensive testing of this instrument under different conditions will help CBER to study and understand the discrepancy in the results obtained by different thrombin generation assays, which is important for standardization of the assays and interpretation of results.