| Device |
non-variola orthopoxvirus real-time pcr primer and probe set |
| Definition |
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture. |
| Physical State |
Provided in the device are Non-variola Orthopoxvirus Real-time PCR Assay Reagents which include primers and probes, positive controls, and an extraction control. |
| Technical Method |
A Non-variola Orthopoxvirus Real-time PCR Assay method which includes nucleic acid isolation, amplification and detection of nucleic acid using a PCR instrument. A set of primers and probes are used for the in vitro detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture. |
| Target Area |
Human Clinical Samples (e.g., pustular or vesicular rash specimens) and viral cell culture lysates |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PBK |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3315
|
|---|
| 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 |
