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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device multiple autoantibodies, indirect immunofluorescent, antigen, control
Regulation Description Multiple autoantibodies immunological test system.
Product CodeDBL
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNO CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1


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