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Dear BCA LABORATORY, I hope this message finds you well. We are writing to inform you and get your feedback on a change to the regulatory classification of our blank matrix products. After a comprehensive review, we have determined that these products are more appropriately classified for non-diagnostic use. This reclassification better aligns with the intended use of these products as substrate materials rather than diagnostic devices. We want to emphasize that there will be no change to the composition, quality, or performance of the products, just to their regulatory classification. We are considering two approaches: - RUO (Research Use Only) labeling for the blank matrix products - General Biological Raw Material classification for biological matrices and General Laboratory Reagent classification for synthetic matrices Before making any changes, we want to better understand how this adjustment might impact your business operations. In particular, we’d like your input on: • Whether a shift from IVD to non-diagnostic use would affect your use of our products. • Whether RUO or General Biological Raw Material/General Laboratory Reagent classification would be preferable for your operations • Any regulatory or operational considerations on your side that we should be aware of. • The preferred channels through which you would like to be notified of future updates (e.g., point of contact) Your feedback will help ensure that we maintain alignment with your needs and provide the right level of communication and support as we move forward. Please feel free to share your thoughts at your earliest convenience. We greatly value your partnership and want to make this process as smooth and transparent as possible. Thank you, and we look forward to your input. Best regards, UTAK Laboratories