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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 Class Implantable

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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

HardyCHROM - 00816576025695

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 - 00816576025671

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

N/A - 00816576025657

Starch Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Starch Agar is used in determining starch hydrolysis by microorganisms.
HARDY DIAGNOSTICS
G294
In Commercial Distribution

  • 00816576025640 ()
  • 00816576025657 ()
G294

  • Differential/selective agar culture medium IVD
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