Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Medical specialty
Microbiology
Device class
2
Regulation number
866.1640
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem