ThinPrep Pap Test

Basic Information

• Brand Name: ThinPrep Pap Test
• Primary DI: 15420045504004
• Version / Model: ThinPrep Pap Test Physician Kit
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-15
• Public Version: 5
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 4c17af15-c5d7-4f94-b88e-9efb8792da33

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
57952	Cytology specimen container IVD, transport buffer	A covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045504004	GS1

Premarket Submissions

Submission Number	Supplement Number
P950039	028