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U.S. Department of Health and Human Services

Product Classification

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Device antismooth muscle antibody, indirect immunofluorescent, antigen, control
Regulation Description Antismooth muscle antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDBE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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