| Device |
reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification |
| Definition |
2009 h1n1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 h1n1 influenza virus in human respiratory specimens. |
| Physical State |
Reagent Kit |
| Technical Method |
Nucleic acid amplification or antigen detection assays |
| Target Area |
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device. |
| Review Panel |
Microbiology |
|---|
| Product Code | OPU |
|---|
|
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
|
| Third Party Review |
Not Third Party Eligible |
