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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device zinc transporter 8 auto-antibody
Regulation Description Zinc transporter 8 autoantibody immunological test system.
Definition The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
Product CodePHF
Regulation Number 866.5670
Device Class 2