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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., serum) to determine the oncofetal antigen soft keratin (i.e., cytokeratin) fragment 19, referred to as CYFRA 21-1, typically found in the serum of patients with malignant tumors. The detection of the tumor marker CYFRA 21-1 (cytokeratin 19) is used in monitoring of non-small cell lung cancer and squamous cell carcinomas; its presence in pleural effusion is considered an aid for discriminating benign from malignant diseases.
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