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U.S. Department of Health and Human Services

Product Classification
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Device fibrin monomer paracoagulation
Regulation Description Fibrin monomer paracoagulation test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBN
Submission Type Enforcement Discretion
Regulation Number 864.7300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092798.htm] 
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