Device |
positive blood culture identification and ast kit |
Definition |
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets. |
Physical State |
In vitro diagnostic device |
Technical Method |
Direct Fluorescence in situ hybridization (FISH) identification and antimicrobial susceptibility testing (AST) of microbes growing in positive blood cultures |
Target Area |
Direct identification and antimicrobial susceptibility testing of microbes in positive blood cultures |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PRH |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.1650
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |