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Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA product code PTJ · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.1640
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-27 – 2025-06-04

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem

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