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U.S. Department of Health and Human Services

Product Classification

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Device reagent, borrelia serological reagent
Regulation Description Treponema pallidum treponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLSR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3830
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm238853.htm] 
Third Party Review Not Third Party Eligible
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