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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, antimicrobial resistance marker, direct specimen
Regulation Description Antimicrobial susceptibility test powder.
Definition To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Physical State Single-use, disposable assay cartridges and instrument system.
Technical Method Qualitative nucleic acid amplification test.
Target Area Not applicable.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePOC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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