Product Classification

• Device: fibrinogen and fibrin split products, antigen, antiserum, control
• Regulation Description: Fibrinogen/fibrin degradation products assay.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: DAP
• Submission Type: 510(k)
• Regulation Number: 864.7320
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline
• CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.