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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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OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD
OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution

  • 10758750005482 ()
936415F

  • Laboratory instrument/analyser application software IVD
OSP Workstation, 166 MHz (computer)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936396
In Commercial Distribution

  • 10758750005451 ()
936396

  • Enzyme immunoassay (EIA) analyser IVD
AutoWash 96, SLT/AutoWash 96, SLT, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936380F
In Commercial Distribution

  • 10758750005420 ()
936380F

  • Microplate washer IVD
Incubator, KVM Model 120, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
934090F
In Commercial Distribution

  • 10758750005352 ()
934090F

  • Microplate/tube/assay card incubator IVD
First Aid Kit for car makers, to be placed into vehicles
Tek Corporation
DIN-131642022-02
In Commercial Distribution

  • 08052691610008 ()
  • 08052691610015 ()
  • 08052691610022 ()
  • 08052691610039 ()


  • Medical bag
LDR First Aid Kit All-purpose 140 pieces
Cardinal Health 110, Inc.
5956727
In Commercial Distribution

  • 60096295144859 ()
  • 00096295144857 ()
5956727

  • First aid kit, medicated
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002868 ()
  • 00895160002861 ()
MD-8147 2T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution

  • 10895160002790 ()
  • 00895160002793 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002783 ()
  • 00895160002786 ()
  • 20895160002780 ()
MD-8147-20T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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