ThinPrep Pap Test

GUDID 15420045514652

Hologic, Inc.

Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer

• Primary Device ID: 15420045514652
• NIH Device Record Key: 30012bb8-784e-4b6a-b01d-57e09b3fa22a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep Pap Test
• Version Model Number: ThinPrep Pap Test PreservCyt Solution
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045514652 [Primary]
GS1	25420045514659 [Package]; Package: TRAY [25 Units]; In Commercial Distribution
GS1	35420045514656 [Package]; Contains: 25420045514659; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950039
• 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-27
• Device Publish Date: 2021-09-17

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