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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
Definition Intended for the in-vitro measurement (semi-quantitative) of Zinc Transporter 8 Antibody in human serum. The test result is to be used as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The assay result 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