| Device |
mers-cov and common respiratory pathogens multiplex nucleic acid detection system |
| Definition |
A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities. |
| Physical State |
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection systems are in vitro diagnostic devices that consist of reagents and associated instrumentation for detection and identification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. |
| Technical Method |
A qualitative in vitro diagnostic assay that detects and identifies MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. |
| Target Area |
In vitro diagnostic device |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Microbiology |
|---|
| Product Code | PZF |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.4001
|
|---|
| 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 |
