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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 pallidumtreponemal test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLSR
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  • Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of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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