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U.S. Department of Health and Human Services

Product Classification

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Device test, urea adult and pediatric (breath),
Regulation Description Campylobacter fetus serological reagents.
Definition Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.
Physical State Human Breath
Technical Method System utilizes an Infrared Spectrophotometer
Target Area Stomach, esophagogastroduodenoscopy
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOZA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Regulation Number 866.3110
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible