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 Class Implantable

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HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies. HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca.
HARDY DIAGNOSTICS
J28
In Commercial Distribution

  • 00816576026838 ()
  • 00816576026845 ()
J28

  • Multiple formulation agar culture medium IVD
  • Multiple bacteria carbapenemase production IVD, kit, chromogenic
BlueMount™, permanent fungal stain, lactophenol cotton blue with PVA, 15ml each A permanent slide mounting media for mycology specimens that contains the stain lactophenol cotton blue. Produces a long lasting permanently stained slide. Contains polyvinyl alcohol (PVA) that will dry and set up hard to create a perfectly preserved slide.
HARDY DIAGNOSTICS
Z137
In Commercial Distribution

  • 00819398027182 ()
Z137

  • Biological stain IVD
Viral Transport Medium, 3ml, order by 100/ box For the collection and transport of specimens to the lab for the recovery/identification of viruses. Refrigerate after inoculation. For long term storage after inoculation, freeze at -70C. Do not moisten swab with the media prior to use. Refer to the IFU.
HARDY DIAGNOSTICS
R64BX
Not in Commercial Distribution

  • 00816576024537 ()
  • 00816576024575 ()
R64BX

  • General specimen container IVD, additive/medium
CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate esterase, 25 disks tests per package Rapid test for the detection of the enzyme butyrate esterase in bacteria isolated on culture media for the presumptive identification of Branhamella (Moraxella) catarrhalis. Performs a butyrate test within 5 minutes. Simply moisten disk, inoculate with organism, then wait for the development of a red color.
HARDY DIAGNOSTICS
Z110
In Commercial Distribution

  • 00819398027267 ()
  • 00819398028554 ()
Z110

  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent
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