MKQ — Processor, Cervical Cytology Slide, Automated Class III

FDA Device Classification

Classification Details

Product Code
MKQ
Device Class
Class III
Regulation Number
Submission Type
Review Panel
PA
Medical Specialty
Unknown
Implant
No

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.