ThinPrep Pap Test

GUDID 15420045514683

Hologic, Inc.

Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD Microscope slide maker IVD
Primary Device ID15420045514683
NIH Device Record Key6f18b78f-5204-4b7c-a26e-4e326595ca0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinPrep Pap Test
Version Model NumberThinPrep Pap Test Filters
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045514683 [Unit of Use]
GS125420045514680 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-07
Device Publish Date2021-09-29

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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