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Regulatory Landscape Overview. While many PCR assays are developed for research applications there are further considerations for those that are being developed to become diagnostic assays or to be performed in support of Biologics License Application (BLA), New Drug Application (NDA), Premarket Approval (PMA), 510(K) or other regulatory filing.Regulatory Agencies & Conclusions - PCR Technologies Regulatory Landscape Overview. While many PCR assays are developed for research applications there are further considerations for those that are being developed to become diagnostic assays or to be performed in support of Biologics License Application (BLA), New Drug Application (NDA), Premarket Approval (PMA), 510(K) or other regulatory filing.Sekisui DiagnosticsSekisui Diagnostics delivers differentiated products, instrument systems and services that support the improvement of patient care worldwide.

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