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U.S. Department of Health and Human Services

Product Classification

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Device reagent, russel viper venom
Regulation Description Russell viper venom reagent.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGIR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Third Party Review
Accredited Persons

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