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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device factor xiii a, s, antigen, antiserum, control
Regulation Description Factor XIII, A, S, immunological test system.
Product CodeDBT
Regulation Number 866.5330
Device Class 1


Premarket Reviews
ManufacturerDecision
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1

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