Product Classification

• Device: c-reactive protein, antigen, antiserum, and control
• Regulation Description: C-reactive protein immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DCK
• 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

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.