Product Classification

• Device: test, urea (breath or blood)
• Regulation Description: Campylobacter fetusserological reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: MSQ
• 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• Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori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

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.