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U.S. Department of Health and Human Services

Product Classification

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Device antinuclear antibody, antigen, control
Regulation Description Antinuclear antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeLKJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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