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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibodies, gliadin
Product CodeMST
Regulation Number 866.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
AESKU.DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US INC
  SUBSTANTIALLY EQUIVALENT 2
GRIFOLS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Phadia US Inc II Jun-30-2023
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