- Physicians Office Resource

For use with a ThinPrep® processor for gynecological specimens.
ThinPrep Pap Test - ThinPrep® Pap Test Filters, 100pk tray

Device Description

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.

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 Identifiers

Device Id: 25420045501086

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: 15420045501089

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: 45420045501080

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 25420045501086

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: 35420045501083

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 25420045501086

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

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