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U.S. Department of Health and Human Services

Product Classification

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Device helicobacter pylori
Regulation Description Campylobacter fetusserological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLYR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3110
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Documents
  • Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
  • Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094257.pdf] 
Third Party Review
Accredited Persons

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