Home » Baebies Wins FDA de novo Clearance for Newborn Screening Platform
Baebies Wins FDA de novo Clearance for Newborn Screening Platform
February 7, 2017
Durham, North Carolina–based, Baebies has received de novo clearance from FDA for Seeker, which is a screening platform for newborn babies.
The assay measures for potential insufficient lysosomal enzymes from newborn dried blood spot specimens. — Cynthia Jessup
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