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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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N/A - 00816576025923

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

N/A - 00816576025909

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

N/A - 00816576025886

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

N/A - 00816576025862

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

N/A - 00816576025848

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

N/A - 00816576025831

MacConkey Agar USP, 15x100 monoplate, 10/pk For isolation and differentiation of gram-negative bacteria. Some ingredients are very light sensitive. Store and incubate media in the dark
HARDY DIAGNOSTICS
G35
In Commercial Distribution

  • 00816576025824 ()
  • 00816576025831 ()
G35

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576025794

HardyCHROM™ SS NoPro Agar, 15x100mm Plate, 21mL. Hardy Diagnostics HardyCHROM™ SS NoPro (no-Proteus) Agar is recommended for the selective isolation and differentiation of Salmonella and Shigella spp. from stool. HardyCHROM™ SS NoPro Agar is intended as a primary screening tool to distinguish Salmonella and Shigella spp. from non-pathogenic enteric bacteria based on colony color, while inhibiting the growth and characteristic swarming of Proteus spp. The enhanced inhibition of Proteus reduces the expense involved in working up non-pathogens that could mimic enteric pathogens. Further species confirmation of suspect colonies via conventional or automated methods is recommended.
HARDY DIAGNOSTICS
G327
In Commercial Distribution

  • 00816576025787 ()
  • 00816576025794 ()
G327

  • Differential/selective agar culture medium IVD

N/A - 00816576025756

SP4 Agar with Arginine, 15x60mm Plate, 11ml. Hardy Diagnostics SP4 Media are recommended for the isolation, differentiation and maintenance of mycoplasma, including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
HARDY DIAGNOSTICS
G32
Not in Commercial Distribution

  • 00816576025749 ()
  • 00816576025756 ()
G32

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576025732

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 - 00816576025718

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
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