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U.S. Department of Health and Human Services

Product Classification

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Device bence-jones protein, antigen, antiserum, control
Regulation Description Bence-Jones proteins immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeCZQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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