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Finally, the applicant also stated that CMS regulations stipulate that a new device category may be established if the device is not appropriately described by any of the existing categories

mAbs-based approaches In MM, radiolabeled daratumumab, known for its high affinity and specificity for CD38, has been used as a diagnostic tracer for imaging purposes in both preclinical [101, 102] and clinical studies [65, 103]