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U.S. Department of Health and Human Services

Product Classification

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Device system, microbial growth monitor of normally sterile body fluid culture
Regulation Description Microbial growth monitor.
Definition Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
Physical State Single use disposable cartridges
Technical Method Monitor microbial growth by assay in the system
Target Area Human clinical samples
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQBQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2560
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible