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U.S. Department of Health and Human Services

Product Classification

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Device system, test, genotypic detection, resistant markers, enterococcus species
Regulation Description Antimicrobial susceptibility test powder.
Definition The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNIJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible