ThinPrep ASY-15509

GUDID 15420045514621

Hologic, Inc.

General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium
Primary Device ID15420045514621
NIH Device Record Key4adadf9e-aaae-4f75-81da-b995c1e0c239
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinPrep
Version Model NumberUroCyte Vial
Catalog NumberASY-15509
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045514621 [Primary]

FDA Product Code

LEAPRESERVATIVE, CYTOLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-30
Device Publish Date2021-11-22

On-Brand Devices [ThinPrep]

25420045510064FILTER, THINPREP UROCYTE 100 PACK  
25420045509990THINPREP MICROSCOPE, ARCLESS, 72pk
25420045509679NON-GYN Slides
25420045509662NON-GYN Filters, 100 pack
15420045510166Bluing II
15420045510159Rinse II
15420045510128EA
15420045510104OG
15420045509702Bluing 4L PKG. PRODUCT
15420045509696Nuclear 4L PKG. PRODUCT
15420045509689Rinse 4L PKG. PRODUCT
15420045508484UroCyte Vial
15420045508460UroCyte Vial
15420045508453CytoLyt Tube
15420045508446CytoLyt Cup
15420045508408CytoLyt Quart
15420045508361PRESERVCYT QUART
15420045508354CellFyx Device
15420045508316PRESERVCYT VIAL
25420045510057THINPREP SLIDES UROCYTE, 100 pk
25420045508467UroCyte Vial
15420045514775PRESERVCYT VIAL
15420045514621UroCyte Vial
15420045514614CytoLyt Cup
15420045514607CytoLyt Tube

Trademark Results [ThinPrep]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THINPREP
THINPREP
88845760 not registered Live/Pending
Hologic, Inc.
2020-03-24
THINPREP
THINPREP
87527464 5406480 Live/Registered
Hologic, Inc.
2017-07-13
THINPREP
THINPREP
76383992 2858447 Live/Registered
HOLOGIC, INC.
2002-03-19
THINPREP
THINPREP
76383954 2911395 Live/Registered
HOLOGIC, INC.
2002-03-19
THINPREP
THINPREP
74022769 1676316 Live/Registered
Cytyc Corporation
1990-01-25
THINPREP
THINPREP
74022765 not registered Dead/Abandoned
Cytyc Corporation
1990-01-25

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