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 |