| Device |
coccidioides spp. nucleic acid detection system for respiratory specimens |
| Definition |
A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection. |
| Physical State |
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Coccidioides spp. nucleic acids in respiratory specimens. |
| Technical Method |
Qualitative in vitro diagnostic assay that detects and identifies Coccidioides spp. nucleic acids in respiratory specimens. |
| Target Area |
Respiratory clinical specimens from patients suspected of coccidioidomycosis |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | QAA |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3376
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
