| Device |
mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test |
| Definition |
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations. |
| Physical State |
In vitro diagnostic kit |
| Technical Method |
Enzyme-linked immunospot assay |
| Target Area |
Peripheral Blood |
| Review Panel |
Microbiology |
|---|
| Product Code | OJN |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
