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U.S. Department of Health and Human Services

Product Classification

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Device autoantibodies, glutamic acid decarboxylase (gad)
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Physical State Not applicable
Technical Method Immunoassay
Target Area Not applicable
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNWG
Premarket Review Office of In Vitro Diagnostics (OHT7)
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