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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device extractable antinuclear antibody, antigen and control
Regulation Description Antinuclear antibody immunological test system.
Product CodeLLL
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5

Recalls
Manufacturer Recall Class Date Posted
1 Diamedix Corporation II Jun-26-2015

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