ThinPrep Pap Test

GUDID 25420045501109

Hologic, Inc.

Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD Cervical cytology microscopy slide IVD
Primary Device ID25420045501109
NIH Device Record Key398dee87-cda2-4a45-991c-1a936743e328
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinPrep Pap Test
Version Model NumberThinPrep Microscope Slides
Company DUNS018925968
Company NameHologic, Inc.
Device Count100
DM Exempttrue
Pre-market Exemptfalse
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

Handling Environment TemperatureBetween 0 and 15 Degrees Celsius
Handling Environment TemperatureBetween 0 and 15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045501102 [Unit of Use]
GS125420045501109 [Primary]
GS135420045501106 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, cervical cytology slide, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-11

On-Brand Devices [ThinPrep Pap Test]

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

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