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 Code | PMY |
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 |