|
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. |
Product Code | PCH |
Regulation Number |
866.3990
|
Device Class |
2
|
|
|
|