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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tyrosine phosphatase (ia-2) autoantibody assay
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Product CodeOIF
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
KRONUS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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