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U.S. Department of Health and Human Services

Product Classification

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Device test, urea (breath or blood)
Regulation Description Campylobacter fetus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMSQ
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 Document
  • Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
Third Party Review
Accredited Persons

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