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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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No Description
REMEL, INC.
T3491
In Commercial Distribution

  • 00848838091322 ()


  • Isotonic saline reagent IVD
No Description
REMEL, INC.
T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC
In Commercial Distribution

  • 00848838090981 ()


  • Mueller-Hinton broth antimicrobial susceptibility culture medium IVD
SPECTRA ESBL 100/Pk
REMEL, INC.
R01811
In Commercial Distribution

  • 00848838085635 ()
R01811

  • Differential/selective agar culture medium IVD
SPECTRA ESBL 10/Pk
REMEL, INC.
R01810
In Commercial Distribution

  • 00848838085628 ()
R01810

  • Differential/selective agar culture medium IVD
No Description
REMEL, INC.
R30851502
In Commercial Distribution

  • 00848838080913 ()


  • Protease immunohaematology reagent IVD
No Description
REMEL, INC.
R01832
In Commercial Distribution

  • 00848838079160 ()
  • 00848838099939 ()


  • Chromogenic VRE agar culture medium IVD
No Description
REMEL, INC.
R01173
In Commercial Distribution

  • 00848838077135 ()
  • 00848838099427 ()


  • Brain heart infusion (BHI) agar culture medium IVD
No Description
REMEL, INC.
R01830
In Commercial Distribution

  • 00848838076824 ()
  • 00848838099526 ()


  • Chromogenic VRE agar culture medium IVD
No Description
REMEL, INC.
DR0780M
In Commercial Distribution

  • 00848838076817 ()


  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for non-fastidious and fastidious Gram positive cocci and non fastidious Gram negative organisms, through the use of dedicated Sensititre® SWIN software. MIC and BP Susceptibility plates can either be read manually or automatically on the Sensititre OptiRead™, Autoreader® or the ARIS® in combination with theAutoreader® or OptiRead™.
REMEL, INC.
V3030
In Commercial Distribution

  • 00848838074530 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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