ThinPrep ASY-11355
GUDID 15420045514157
Accessory to the Genesis™ processor for automated label printing on a specimen tube.
Hologic, Inc.
Microscope slide maker IVD| Primary Device ID | 15420045514157 |
| NIH Device Record Key | 9f7111c5-c675-437b-9e17-b26893425a7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThinPrep |
| Version Model Number | APTIMA TUBE PRINTER, THINPREP GENESIS |
| Catalog Number | ASY-11355 |
| 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
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 |
| 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 |
| 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 | 15420045514157 [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 |
Trademark Results [ThinPrep]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THINPREP 88845760 not registered Live/Pending |
Hologic, Inc. 2020-03-24 |
 THINPREP 87527464 5406480 Live/Registered |
Hologic, Inc. 2017-07-13 |
 THINPREP 76383992 2858447 Live/Registered |
HOLOGIC, INC. 2002-03-19 |
 THINPREP 76383954 2911395 Live/Registered |
HOLOGIC, INC. 2002-03-19 |
 THINPREP 74022769 1676316 Live/Registered |
Cytyc Corporation 1990-01-25 |
 THINPREP 74022765 not registered Dead/Abandoned |
Cytyc Corporation 1990-01-25 |
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