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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antinuclear antibody, indirect immunofluorescent, antigen, control
Product CodeDHN
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
AESKU DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
AESKU. SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN U.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNO CONCEPTS, NA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories III Aug-22-2011
2 Immuno Concepts Inc III Apr-06-2009
3 Inova Diagnostics Incorporated III Nov-23-2011
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