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U.S. Department of Health and Human Services

Product Classification

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Device autoantibodies,skin(desmoglein 1 and desmoglein 3)
Regulation Description Multiple autoantibodies immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNBO
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
Third Party Review Not Third Party Eligible
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