ThinPrep Pap Test

GUDID 15420045504004

Hologic, Inc.

Cytology specimen container IVD, transport buffer

• Primary Device ID: 15420045504004
• NIH Device Record Key: 4c17af15-c5d7-4f94-b88e-9efb8792da33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep Pap Test
• Version Model Number: ThinPrep Pap Test Physician Kit
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950039

FDA Product Code

• MKQ: Processor, cervical cytology slide, automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-15

On-Brand Devices [ThinPrep Pap Test]

• 25420045501109: ThinPrep Microscope Slides
• 25420045501086: ThinPrep Pap Test Filters
• 15420045504011: ThinPrep Pap Test Physician Kit
• 15420045504004: ThinPrep Pap Test Physician Kit
• 15420045501072: ThinPrep Pap Test PreservCyt Solution
• 15420045514652: ThinPrep Pap Test PreservCyt Solution
• 15420045514683: ThinPrep Pap Test Filters