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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 ro60 autoantibodies
Regulation Description Antinuclear antibody immunological test system.
Definition Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.
Product CodePET
Regulation Number 866.5100
Device Class 2