Published in Medical Letter on the CDC and FDA, December 7th, 2003
The supplement was filed with the United States Food and Drug Administration and will be followed by filings with regulatory authorities in other countries. Upon approval, Kogenate FS with Bio-Set will be the first and only self-contained device that provides a prefilled syringe for rapid and safe reconstitution and infusion without exposed needles. Bio-Set will be available exclusively with Kogenate FS and...
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