Product Classification

• Device: reagent, russel viper venom
• Regulation Description: Russell viper venom reagent.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GIR
• Submission Type: 510(k)
• Regulation Number: 864.8950
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• 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 Program

Accredited Persons

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