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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device uridine-5-diphosphoglucose, nad (u.v.), alpha-d galactose-1-phosphate
Regulation Description Galactose-1-phosphate uridyl transferase test system.
Product CodeJLJ
Regulation Number 862.1315
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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