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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates
Regulation Description Antimicrobial susceptibility test powder.
Definition Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Product CodePTJ
Regulation Number 866.1640
Device Class 2

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