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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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SENSITITRE YEASTONE SUSCEPTIBILITY PLATES - 00848838036835

The Sensititre® YeastOne® Susceptibility system is a micro-version of the broth dilution susceptibility test. Various antifungal agents are serially diluted to concentrations bridging the range of the clinical interest in autoclaved diluent, which contains a colorimetric growth indicating compound. Each micro-dilution plate is individually packaged in foil. After inoculation, plates are sealed with an adhesive seal, incubated at 35°C for 24 hours and examined for growth.
REMEL, INC.
YO10
In Commercial Distribution

  • 00848838036835 ()


  • Multiple-type pathogen antimicrobial susceptibility testing kit IVD

REMEL - 00848838031922

OADC Enrichment (2ml) PK/10
REMEL, INC.
R450600
Not in Commercial Distribution

  • 00848838031922 ()
R450600

  • Culture medium antimicrobial supplement IVD

REMEL - 00848838031861

Tinsdale Enrichment (3.3ml) PK/10
REMEL, INC.
R45045
Not in Commercial Distribution

  • 00848838031861 ()
R45045

  • Culture medium antimicrobial supplement IVD

Pathotec - 00848838031151

Pathotec CO 100/PK (25/vial-4vial/PK)
REMEL, INC.
R38191
In Commercial Distribution

  • 00848838031151 ()
R38191

  • Bacterial species differentiation disc IVD

REMEL - 00848838028915

PYR Disk w/Reagent 100TST/KT
REMEL, INC.
R30854401
In Commercial Distribution

  • 00848838028915 ()
R30854401

  • Bacterial species differentiation disc IVD

REMEL - 00848838028892

PYR Disk w/Reagent 50TST/KT
REMEL, INC.
R30854301
In Commercial Distribution

  • 00848838028892 ()
R30854301

  • Bacterial species differentiation disc IVD

Remel - 00848838028779

Candida albicans screen 50TST/KT
REMEL, INC.
R30851401
In Commercial Distribution

  • 30848838028770 ()
  • 00848838028779 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit

Remel - 00848838028625

LAP Disk w/Reagent 50TST/KT
REMEL, INC.
R30168501
In Commercial Distribution

  • 30848838028626 ()
  • 00848838028625 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit

REMEL - 00848838027826

Beta Lactam Reagent Disk 25Disk/VL
REMEL, INC.
R261605
In Commercial Distribution

  • 00848838027826 ()
R261605

  • Bacterial species differentiation disc IVD

REMEL - 00848838027628

Oxy-Swab 100/PK (25/env-4env/PK)
REMEL, INC.
R249348
In Commercial Distribution

  • 00848838027628 ()
R249348

  • Bacterial species differentiation disc IVD
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