| Device |
laboratory developed test |
| Definition |
A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by clia certified clinical laboratory for use in that laboratory.This product is neither an analyte specific reagent nor are the components for research use only.The reporting of adverse events is voluntary and registering and listing is not required. |
| Physical State |
In vitro diagnostic device |
| Technical Method |
In vitro diagnostic device |
| Target Area |
In vitro diagnostic device |
| Review Panel |
Immunology |
|---|
| Product Code | OQS |
|---|
|
Not Classified Reason
|
Enforcement Discretion
|
|---|
| Submission Type |
Enforcement Discretion
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
