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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
Product CodeLLL
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMEDICAL DIAGNOSTICS (BMD) SA
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
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PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Diamedix Corporation II Jun-26-2015
2 Diamedix Corporation II May-21-2012
3 Immuno Concepts Inc III Apr-06-2009
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