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U.S. Department of Health and Human Services

Product Classification

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Device insulin autoantibody kit
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
Physical State Not applicable
Technical Method Immunoassay
Target Area Not applicable
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOCN
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons