ThinPrep Imaging System

GUDID 15420045500938

Hologic, Inc.

Laboratory instrument/analyser application software IVD
Primary Device ID15420045500938
NIH Device Record Keya318309a-c08f-4725-826b-6fad23cd6825
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinPrep Imaging System
Version Model NumberThinPrep Imaging System Imaging Station
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -28 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045500938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNMREADER, 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 Date2014-09-02

On-Brand Devices [ThinPrep Imaging System]

25420045501093ThinPrep Imaging System Slides
15420045508163Thinprep Imaging System Computer
15420045508156ThinPrep Imaging System Server
15420045508040ThinPrep Imaging System Review Scope
15420045507265ThinPrep Imaging System Workstation
15420045507258ThinPrep Imaging System Workstation
15420045504103ThinPrep Imaging System Workstation
15420045504097ThinPrep Imaging System Workstation
15420045504080ThinPrep Imaging System Workstation
15420045504042ThinPrep Imaging System Computer
15420045504035ThinPrep Imaging System Workstation
15420045501041ThinPrep Imaging System Computer
15420045501034ThinPrep Imaging System Computer
15420045501027ThinPrep Imaging System Server
15420045501010ThinPrep Imaging System Server
15420045501003ThinPrep Imaging System Server
15420045500990ThinPrep Imaging System Workstation
15420045500983ThinPrep Imaging System Workstation
15420045500976ThinPrep Imaging System Workstation
15420045500945ThinPrep Imaging System Workstation
15420045500938ThinPrep Imaging System Imaging Station
15420045500921ThinPrep Imaging System Imaging Station
15420045500914ThinPrep Imaging System Imaging Station
15420045500907ThinPrep Imaging System Review Scope
15420045500891ThinPrep Imaging System Review Scope
15420045512535ThinPrep Imaging System Workstation
15420045512511ThinPrep Imaging System Workstation
15420045513716Thinprep Imaging System Computer
15420045515062ThinPrep Imaging System Computer

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