Home GUDID 15420045515062
ThinPrep Imaging System
Primary DI 15420045515062
Brand ThinPrep Imaging System
Company Hologic, Inc.
Model ThinPrep Imaging System Computer
Catalog number CMP-01836
Device description Computer to operate the ThinPrep® Review Scope Manual+.
Published 2022-08-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name MNM READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNM Reader, Cervical Cytology Slide, Automated Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15420045515062 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15420045515062 15420045515062
GMDN Terms# Term, Definition table Term Definition Laboratory instrument/analyser application software IVD An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 16 Degrees Celsius 32 Degrees Celsius Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -29 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 018925968 Device count 1 DM exempt true Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00382904914905 BD™ FocalPoint™ Slide Profiler Refurbished BECTON, DICKINSON AND COMPANY MNM 2023-09-08 15420045513716 Thinprep Imaging System Hologic, Inc. MNM 2020-06-24 00382904914646 BD FocalPoint Slide Profiler BECTON, DICKINSON AND COMPANY MNM 2019-12-03 15420045512511 ThinPrep Imaging System Hologic, Inc. MNM 2019-12-03 15420045512535 ThinPrep Imaging System Hologic, Inc. MNM 2019-12-03 00382904910907 BD FocalPoint™ Slide Profiler Refurbished BECTON, DICKINSON AND COMPANY MNM 2019-06-27 15420045508156 ThinPrep Imaging System Hologic, Inc. MNM 2018-10-13 15420045508040 ThinPrep Imaging System Hologic, Inc. MNM 2018-05-23 15420045508163 Thinprep Imaging System Hologic, Inc. MNM 2017-10-13 00382904901899 BD FocalPoint™ GS Review Station BECTON, DICKINSON AND COMPANY MNM 2017-09-08 15420045507258 ThinPrep Imaging System Hologic, Inc. MNM 2017-02-23 15420045507265 ThinPrep Imaging System Hologic, Inc. MNM 2017-02-23 00382904910853 BD FocalPoint BECTON, DICKINSON AND COMPANY MNM 2015-07-22 00382904910860 BD FocalPoint BECTON, DICKINSON AND COMPANY MNM 2015-07-22 00382904910877 BD FocalPoint BECTON, DICKINSON AND COMPANY MNM 2015-07-22 15420045504035 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-22 15420045504103 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-22 15420045504042 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-08 15420045504080 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-08 15420045504097 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-08 15420045500891 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500907 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500914 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500921 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500938 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500945 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500976 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500983 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045500990 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02 15420045501003 ThinPrep Imaging System Hologic, Inc. MNM 2014-09-02