Device |
kit, cell screening, fetal |
Review Panel |
Pathology |
Product Code | MTI |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Not Classified Reason
|
Unknown
|
Submission Type |
Contact ODE
|
Device Class |
Not Classified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|