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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antinuclear antibody (enzyme-labeled), antigen, controls
Product CodeLJM
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHADIA GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K083188  VARELISA RECOMBI ANA SCREEN, MODEL 12 596

Recalls
Manufacturer Recall Class Date Posted
1 Calbiotech Inc II Mar-05-2010
2 Zeus Scientific Inc II Mar-31-2009
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