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U.S. Department of Health and Human Services

Product Classification

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Device gastrointestinal pathogen panel multiplex nucleic acid-based assay system
Definition A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens.The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Physical State Gastrointestinal pathogen panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal microbial nucleic acids extracted from human stool specimens.
Technical Method A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Target Area In vitro diagnostic device
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePCH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3990
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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