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U.S. Department of Health and Human Services

Product Classification

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Device system, test, beta-2-microglobulin immunological
Regulation Description Beta-2-microglobulin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeJZG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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