Inactive

The FDA/CBER/OTAT requires brand name or equal ST Genesia to support global test to provide an evaluation of the coagulation potential of a plasma sample. The ST Genesia instrument will be account for... The FDA/CBER/OTAT requires brand name or equal ST Genesia to support global test to provide an evaluation of the coagulation potential of a plasma sample. The ST Genesia instrument will be account for about 90% of the total load of our lab. This instrument will be uses normalization, common calibration for all samples and utilizes additional 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 its results.