Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.

Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.
ThinPrep - ThinPrep Genesis Processor

An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue, cytology specimens, or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MKQ

Device Name: Processor, Cervical Cytology Slide, Automated

Device Class: 3

Physical State: N/A

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.

Submission Type ID: 2

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045513860

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A