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RE: UTAK Feedback Request - RUO Blank Matrix Labeling
Nov 10, 2025 10:03 PM
Hello Raleigh,
We welcome your regulatory classification of the blank matrix products.
· Whether a shift from IVD to non-diagnostic use would affect your use of our products.
--- We believe that sales opportunities will increase.
· Whether RUO or General Biological Raw Material/General Laboratory Reagent classification would be preferable for your operations.
--- If it is classified as a general laboratory reagent, it will be easy to sell.
· Any regulatory or operational considerations on your side that we should be aware of.
--- Please provide the evidence and documents necessary to judge with general laboratory reagents.
· The preferred channels through which you would like to be notified of future updates (e.g., point of contact).
--- Attn: Young Jae Jang
Phone: 82-1-31-903-2500
Fax: 82-1-31-903-2535
Email: yjjang777@naver
Thank you for your help all the time.
Kind regards,
Young Jae Jang
C.E.O