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U.S. Department of Health and Human Services

Product Classification
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Device multiple autoantibodies, indirect immunofluorescent, antigen, control
Regulation Description Multiple autoantibodies immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDBL
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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