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Abbott Tumor Marker-MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

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Please provide the relevant document that describes the acceptance criteria and the study that proves the device meets the acceptance criteria. The provided text is an FDA clearance letter and an Indications for Use statement, which do not contain the detailed information required to answer your request about acceptance criteria, study design, and performance metrics.

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