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They are classified as bulk drug substances and are available only through a licensed prescribing provider and compounding pharmacy

Future studies are needed to validate this screening index and compare to existing indices

M., ONeil, C

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We note that if Septicyte RAPID is substantially similar to SeptiCyte LAB, we believe the newness period for this technology would begin on April 6, 2017 with the 510(k) approval date for SeptiCyte LAB and, therefore, because the 3-year anniversary date of the technology's entry onto the U.S