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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-ss-a 52 autoantibodies
Regulation Description Antinuclear antibody immunological test system.
Definition The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Product CodeOBE
Regulation Number 866.5100
Device Class 2


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ManufacturerDecision
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

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