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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Single use, disposable
Technical Method Biochemical hydrolysis
Target Area Not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePTJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible