| Device |
fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp. |
| Definition |
The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection. |
| Physical State |
In vitro diagnostic devices and reagents that consist of slides, fixatives, fluorescently labeled probes, buffers, and associated instrumentation (if applicable) for the detection and identification of Plasmodium spp. parasites in clinical whole blood smear specimens. |
| Technical Method |
Fluorescence In Situ Hybridization using labeled nucleic acid probes |
| Target Area |
Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PYN |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3367
|
|---|
| 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 |
