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U.S. Department of Health and Human Services

Product Classification

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Device c-reactive protein, antigen, antiserum, and control
Regulation Description C-reactive protein immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDCK
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
Guidance Document
  • Guidance for Industry - Review Criteria for Assessment of C - Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays
Third Party Review
Accredited Persons

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