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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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TSA Plate, USP, 15x100 monoplate, 10 packs/case (Tryptic Soy Agar) For the cultivation of microorganisms
HARDY DIAGNOSTICS
G60BX
In Commercial Distribution

  • 00816576025978 ()
  • 00816576025992 ()
G60BX

  • Basic/simple nutrient agar culture medium IVD
PC Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PC ( Pseudomonas cepacia ) Agar is recommended for the selective isolation of Burkholderia ( Pseudomonas ) cepacia from clinical and environmental materials.
HARDY DIAGNOSTICS
G48
In Commercial Distribution

  • 00816576025916 ()
  • 00816576025923 ()
G48

  • Differential/selective agar culture medium IVD
Mannitol Salt Agar, USP, 15x100 monoplate, 10/pk For the selective isolation and differentiation of Staphylococcus spp.
HARDY DIAGNOSTICS
G40
In Commercial Distribution

  • 00816576025893 ()
  • 00816576025909 ()
G40

  • Differential/selective agar culture medium IVD
MacConkey Agar with MUG, 15x100mm Plate, 18ml. Hardy Diagnostics MacConkey Agar with MUG is used for the presumptive identification of Escherichia coli.
HARDY DIAGNOSTICS
G37
Not in Commercial Distribution

  • 00816576025879 ()
  • 00816576025886 ()
G37

  • Differential/selective agar culture medium IVD
MacConkey Agar with Sorbitol, 15x100mm Plate, 18ml. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
G36
In Commercial Distribution

  • 00816576025855 ()
  • 00816576025862 ()
G36

  • Differential/selective agar culture medium IVD
MacConkey Agar USP, 15x100 monoplate, 10 packs/case For isolation and differentiation of gram-negative bacteria. Some ingredients are very light sensitive. Store and incubate media in the dark
HARDY DIAGNOSTICS
G35X
In Commercial Distribution

  • 00816576025824 ()
  • 00816576025848 ()
G35BX

  • Differential/selective agar culture medium IVD
HardyCHROM™ UTI, 15x100mm Plate, 18ml. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.
HARDY DIAGNOSTICS
G313
In Commercial Distribution

  • 00816576025725 ()
  • 00816576025732 ()
G313

  • Differential/selective agar culture medium IVD
HardyCHROM™ Staph aureus, 15x100mm Plate, 18ml. HardyCHROM™ Staph aureus is a chromogenic medium recommended for the isolation, differentiation, and enumeration of Staphylococcus aureus by colony color.
HARDY DIAGNOSTICS
G311
In Commercial Distribution

  • 00816576025701 ()
  • 00816576025718 ()
G311

  • Differential/selective agar culture medium IVD
HardyCHROM™ Salmonella, 15x100mm Plate, 18ml. HardyCHROM™ Salmonella is a chromogenic medium recommended for the selective isolation and differentiation of Salmonella spp. from other members of the family Enterobacteriaceae based on colony color.
HARDY DIAGNOSTICS
G309
In Commercial Distribution

  • 00816576025688 ()
  • 00816576025695 ()
G309

  • Differential/selective agar culture medium IVD
HardyCHROM™ Candida, 15x100mm Plate, 18ml. HardyCHROM™ Candida is a selective medium recommended for the isolation and identification of yeasts. This medium also allows for the differentiation of C. albicans , C. tropicalis and C. krusei based on differences in colony morphology and color. This medium facilitates the detection of mixed yeast cultures.
HARDY DIAGNOSTICS
G301
In Commercial Distribution

  • 00816576025664 ()
  • 00816576025671 ()
G301

  • Differential/selective agar culture medium IVD
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