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Abstract: . . . features control all aspects of the analytical process, as defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . . . . The VerifyNow quality control features control all aspects of the analytical process, as defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . . . . VerifyNow quality control features control all aspects of the analytical process, as defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . . . . as defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . . . . defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . . . . mixing parameters and sample data acquisition. o Confirms correct calibration parameters. o Simulates assay testing at two levels of results, to check correct data acquisition and calculations. Specifically, the EQC measures two levels of turbidimetric signal that verify the dynamic range of the instrument. One of these signals is at the level that would be observed in a patient with a minimal amount of platelet aggregation (Negative . . . . . . features, which have been designed and incorporated into the system. The VerifyNow quality control features control all aspects of the analytical process, as defined in the CLIA Regulation: • Test system – instrument and reagent system • Operator • Environmental factors Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA quality control requirements. 14267 Rev. B Page 8 of 8 . . . --3000,7,214,2924,18312
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