MKQ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
MKQ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.