| 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 |
