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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device antimitochondrial antibody, indirect immunofluorescent, antigen, control
Regulation Description Antimitochondrial antibody immunological test system.
Product CodeDBM
Regulation Number 866.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 1


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