Device |
lower respiratory microbial nucleic acid detection system |
Regulation Description |
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. |
Definition |
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. |
Physical State |
In vitro diagnostic device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms and associated resistance markers in lower respiratory specimens. |
Technical Method |
In vitro diagnostic device that detects and identifies nucleic acid sequences from microorganisms and associated resistance markers in lower respiratory specimens. |
Target Area |
Respiratory specimens from patients with signs and symptoms of respiratory infection. |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QBH |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3985
|
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 |