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U.S. Department of Health and Human Services

Product Classification
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Device hemoglobin, chain specific, antigen, antiserum, control
Regulation Description Hemoglobin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDAM
Submission Type Enforcement Discretion
Regulation Number 866.5470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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