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We note that all comments requesting the reassignment of CPT code 52282 to APC 5376 were related to a device that has not received FDA approval or any exceptions such as an Investigational Device Exemptions (IDE) or PMA/510K Exemptions, and so those comments are out of the scope for this final rule with comment period

Because the exact activity values on a per unit basis can largely fluctuate depending on a number of factors, including the nature of the assay, cell density, age of cells/passage number, culture media used, and end user technique, the specific activity is best defined as a range and we guarantee the specific activity of all our lots will be within the range indicated on the datasheet

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The company markets itself on quality assurance, claiming that every batch undergoes third-party laboratory testing before reaching customers