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New Search Back To Search Results 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 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 british standards institution cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.