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U.S. Department of Health and Human Services

Product Classification

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Device system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony
Regulation Description Antimicrobial susceptibility test powder.
Definition To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.
Physical State single-use, disposable assay cartridge and instrument system
Technical Method qualitative nucleic acid amplification test
Target Area not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePMY
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
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