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U.S. Department of Health and Human Services

Product Classification

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Device radioimmunoassay, thyroxine-binding globulin
Regulation Description Thyroxine-binding globulin test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCEE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 862.1685
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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