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U.S. Department of Health and Human Services

Product Classification

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Device tyrosine phosphatase (ia-2) autoantibody assay
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Physical State n/a
Technical Method Radioimmunoassay
Target Area n/a
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOIF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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 Not Third Party Eligible