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U.S. Department of Health and Human Services

Product Classification

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Device helicobacter pylori
Regulation Description Campylobacter fetus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLYR
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3110
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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