| Device |
processor, cervical cytology slide, automated |
| Definition |
It is a system that is used to collect and prepare cervical cytology specimens for pap stain-based screening for cervical cancer.The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide.They are stained and screened by a cytotechnologist and cytopathologist. |
| Review Panel |
Pathology |
|---|
| Product Code | MKQ |
|---|
| 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 |
|
|
