ThinPrep PRD-04573

GUDID 15420045513860

Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.

Hologic, Inc.

Microscope slide maker IVD

• Primary Device ID: 15420045513860
• NIH Device Record Key: b5640b27-590d-44b4-a7e5-5aef95824b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep
• Version Model Number: ThinPrep Genesis Processor
• Catalog Number: PRD-04573
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513860 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-28
• Device Publish Date: 2024-05-20

On-Brand Devices [ThinPrep]

• 25420045510064: FILTER, THINPREP UROCYTE 100 PACK
• 25420045509990: THINPREP MICROSCOPE, ARCLESS, 72pk
• 25420045509679: NON-GYN Slides
• 25420045509662: NON-GYN Filters, 100 pack
• 15420045510166: Bluing II
• 15420045510159: Rinse II
• 15420045510128: EA
• 15420045510104: OG
• 15420045509702: Bluing 4L PKG. PRODUCT
• 15420045509696: Nuclear 4L PKG. PRODUCT
• 15420045509689: Rinse 4L PKG. PRODUCT
• 15420045508484: UroCyte Vial
• 15420045508460: UroCyte Vial
• 15420045508453: CytoLyt Tube
• 15420045508446: CytoLyt Cup
• 15420045508408: CytoLyt Quart
• 15420045508361: PRESERVCYT QUART
• 15420045508354: CellFyx Device
• 15420045508316: PRESERVCYT VIAL
• 25420045510057: THINPREP SLIDES UROCYTE, 100 pk
• 25420045508467: UroCyte Vial
• 15420045514775: PRESERVCYT VIAL
• 15420045514621: UroCyte Vial
• 15420045514614: CytoLyt Cup
• 15420045514607: CytoLyt Tube
• 15420045514157: Accessory to the Genesis™ processor for automated label printing on a specimen tube.
• 15420045514140: Accessory kit with components for installation of the Genesis™ processor for customers utilizi
• 15420045514133: Accessory kit with components for installation of the Genesis™ processor.
• 15420045513860: Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass micros