Product Classification

• Device: cardiac c-reactive protein, antigen, antiserum, and control
• Regulation Description: C-reactive protein immunological test system.
• Definition: In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: NQD
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5270
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc