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U.S. Department of Health and Human Services

Product Classification
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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.
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 (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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