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U.S. Department of Health and Human Services

Product Classification

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Device system, test, c-reactive protein, rhodamine
Regulation Description C-reactive protein immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDCH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5270
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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