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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Assay Kit includes strip wells coated with ZnT8; 4 level calibrators; positive and negative controls; Zinc biotin; buffer; streptavidin peroxide; diluent; peroxide substrate; wash solution; stop solution
Technical Method ELISA Assay
Target Area Serum (blood) sample
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePHF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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