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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Shenzhen YHLO Biotech Co., Ltd.
UNION-C
In Commercial Distribution

  • 06925912711117 ()
U6103

  • Enzyme immunoassay (EIA) analyser IVD
QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls.
MEDTOX DIAGNOSTICS, INC.
833075
In Commercial Distribution

  • 00690286000070 ()


  • Multiplex analyser IVD, laboratory
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Wallac Oy
5002-0540
In Commercial Distribution

  • 06438147352401 ()
5002-0540

  • Clinical laboratory information system
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Wallac Oy
5002-0180
In Commercial Distribution

  • 06438147153312 ()
5002-0180

  • Clinical laboratory information system
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
Wallac Oy
5002-0130
In Commercial Distribution

  • 06438147153275 ()
5002-0130

  • Clinical laboratory information system
Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Wallac Oy
5002-0500
In Commercial Distribution

  • 06438147320905 ()
5002-0500

  • Clinical laboratory information system
A cleaning cassette solely intended to clean the color Contact Imaging Sensor (CIS) in the MEDTOXScan® Reader.
MEDTOX DIAGNOSTICS, INC.
833076
In Commercial Distribution

  • 00690286000087 ()


  • Multiplex analyser IVD, laboratory
An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.
MEDTOX DIAGNOSTICS, INC.
833073
In Commercial Distribution

  • 00690286000063 ()


  • Multiplex analyser IVD, laboratory
IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,PREVIEW DISPLAY,MDS,120V,#A280-0983
IMAGE DIAGNOSTICS, INC.
MDS, 4K, 120V
In Commercial Distribution

  • 00850977007928 ()
A280-0983

  • Diagnostic x-ray digital imaging system workstation
IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 27IN. TOUCH SCREEN MONITOR,FIXED,MONITOR CART,#A280-0811
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/27IN TOUCH SCREEN MONITOR
In Commercial Distribution

  • 00850977007737 ()
A280-0811

  • Diagnostic x-ray digital imaging system workstation
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