Device |
reagents, non-variola orthopoxvirus nucleic acid. |
Definition |
Nucleic acid-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus and/or diagnosis of Monkeypox in human clinical specimens. |
Physical State |
In Vitro Diagnostic Device including Primers, Probes and/or capture oligos |
Technical Method |
Nucleic acid amplification and/or detection |
Target Area |
The device is an in-vitro diagnostic device used on clinical specimens; none of the body parts will utilize the device or are intended to be affected by the device. |
Review Panel |
Microbiology |
Product Code | QTQ |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Not Classified Reason
|
EUA - Emergency Use Authorization
|
Submission Type |
EUA - Emergency Use Authorization
|
Device Class |
Not Classified
|
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 |