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U.S. Department of Health and Human Services

Product Classification
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Device culture plate imaging system for qualitative assessment of resistant organisms
Regulation Description Automated image assessment system for microbial colonies on solid culture media.
Definition Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.
Physical State In vitro diagnostic device comprising an imaging system and software for analysis.
Technical Method Analysis and interpretation of digital images of colonies on solid chromogenic culture media.
Target Area Clinical specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQQY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2190
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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