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U.S. Department of Health and Human Services

Product Classification

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Device system, test, infectious mononucleosis
Regulation Description Infectious mononucleosis immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeKTN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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