ThinPrep Pap Test

Basic Information

• Brand Name: ThinPrep Pap Test
• Primary DI: 25420045501086
• Version / Model: ThinPrep Pap Test Filters
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2014-09-12
• Public Version: 4
• Public Version Date: 2020-11-16
• Public Version Status: Update
• Public Device Record Key: 1d75828a-9956-4297-8da4-8d0df27b12dd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKQ	Processor, cervical cytology slide, automated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
15110	Microscope slide maker IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25420045501086	GS1
Unit of Use	15420045501089	GS1

Premarket Submissions

Submission Number	Supplement Number
P950039	000