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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Sabouraud Dextrose (SabDex) Agar with Chloramphenicol and Gentamicin / DTM, 15x100mm Biplate, 15ml/15ml. Hardy Diagnostics Dermatophyte Test Medium (DTM) is a selective and differential medium recommended for the cultivation and isolation of pathogenic dermatophytic fungi.
HARDY DIAGNOSTICS
J107
In Commercial Distribution

  • 00816576026395 ()
  • 00816576026401 ()
J107

  • Multiple formulation agar culture medium IVD
BBE / LKV, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bacteroides Bile Esculin Agar (BBE) is recommended for use in the rapid isolation and presumptive identification of Bacteroides fragilis group. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
HARDY DIAGNOSTICS
J102
In Commercial Distribution

  • 00816576024407 ()
  • 00816576026388 ()
J102

  • Multiple formulation agar culture medium IVD
BBE/LKV Biplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp.
HARDY DIAGNOSTICS
AG061
In Commercial Distribution

  • 00816576024414 ()
AG061

  • Multiple formulation agar culture medium IVD
Granada Medium, 15x100mm Plate, 19ml. Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation.
HARDY DIAGNOSTICS
G123
In Commercial Distribution

  • 00816576024988 ()
  • 00816576024995 ()
G123

  • Differential/selective agar culture medium IVD
HardyCHROM™ Candida, for the selective isolation and identification of Candida spp.
HARDY DIAGNOSTICS
GA301
In Commercial Distribution

  • 00816576023264 ()
  • 00816576023981 ()
GA301

  • Differential/selective agar culture medium IVD
Nocardia Hydrolysis Kit for Actinomycetes, 18ml, (Total of 20 tubes) 20x125mm tubes of 4 different media types (5 each of Casein, Xanthine, Hypoxanthine, and Tyrosine Agars, in 20x125mm tubes, deep) (Nocardia Hydrolysis Kit) For use in determining the hydrolysis reaction on casein, xanthine, hypoxanthine, and tyrosine by Nocardia, Actinomycetales, Actinomadura, and Streptomyces spp. Box contains 5 tubes of each media. 20 tubes total. Contains: Casein Agar, Deep 18ml (5) 00819398022941 Xanthine Agar, Deep 18ml (5) 00819398028462 Hypoxathine Agar, Deep 18ml (5) 00819398028479 Tyrosine Agar, Deep 18ml (5) 00819398028486
HARDY DIAGNOSTICS
Z604
In Commercial Distribution

  • 00819398028493 ()
Z604

  • Differential/selective agar culture medium IVD
Basic Fuchsin, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube, For the speciation of Brucella.
HARDY DIAGNOSTICS
Z006
Not in Commercial Distribution

  • 00819398028448 ()
  • 00819398028455 ()
Z006

  • Differential/selective agar culture medium IVD
MycoVue™ Slide Culture System, Potato Flake Agar, ready-to-use, includes cover slip and humidifier, 5 trays per box A ready-to-use slide culture system for the cultivation of fungi. Simplify your fungal slide cultures while saving money, reducing frustration, and eliminating preparation time. Desiccation is prevented with a built in humidity chamber and the culture can be incubated for long periods of time. Device fits conveniently on the microscope stage for easy observation without disturbing the fungal structures.
HARDY DIAGNOSTICS
MV1
In Commercial Distribution

  • 00819398028257 ()
  • 00819398028264 ()
MV1

  • Basic/simple nutrient agar culture medium IVD
CAN Agar, 15x100 monoplate, 10/pk For the cultivation of yeast
HARDY DIAGNOSTICS
G238
In Commercial Distribution

  • 00819398028219 ()
  • 00819398028226 ()
G238

  • Differential/selective agar culture medium IVD
Strep B Carrot Broth Tiles 1000 tiles/bag For the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tile must be added to broth (not included) upon inoculation.
HARDY DIAGNOSTICS
CBT1000
In Commercial Distribution

  • 00819398027649 ()
  • 00819398028134 ()
CBT1000

  • Differential/selective broth culture medium IVD
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