Product Classification

• Device: fibrinogen standard
• Regulation Description: Fibrinogen determination system.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GFX
• Submission Type: 510(k)
• Regulation Number: 864.7340
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• NCCLS H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

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