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U.S. Department of Health and Human Services

Product Classification

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Device antimitochondrial antibody, indirect immunofluorescent, antigen, control
Regulation Description Antimitochondrial antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDBM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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