Device |
culture-based short-term incubation antimicrobial resistance assay |
Definition |
A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection. |
Product Code | QIV |
Regulation Number |
866.1655
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Device Class |
2
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