Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological specimens.
ThinPrep Imaging System - ThinPrep® Imaging System Microscope Slides, 100pk
Device Description
A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of a cervical cytology smear for analysis and/or other investigation. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 25420045501093
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
Device Id: 15420045501096
Device Type: Unit of Use
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
Device Id: 35420045501090
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045501093
Package Quantity: 500
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
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