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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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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
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
Sulfite Polymyxin Milk Agar, 15x100 monoplate, 10/pk For the selective isolation of Clostridium spp. from fecal samples
HARDY DIAGNOSTICS
G251
In Commercial Distribution

  • 00816576025527 ()
  • 00816576025534 ()
G251

  • Differential/selective agar culture medium IVD
Pseudomonas Agar F, 15x100mm Plate, 18ml. Hardy Diagnostics Pseudomonas Agar F is used for the detection and differentiation of Pseudomonas aeruginosa by enhancement of fluorescein production.
HARDY DIAGNOSTICS
G198
In Commercial Distribution

  • 00816576025220 ()
  • 00816576025237 ()
G198

  • Differential/selective agar culture medium IVD
Vogel and Johnson Agar, 15x100mm Plate, 19ml. Hardy Diagnostics Vogel and Johnson Agar is a selective medium used for the detection of coagulase-positive, mannitol-positive Staphylococcus aureus strains in clinical specimens and foods.
HARDY DIAGNOSTICS
G193
In Commercial Distribution

  • 00816576025206 ()
  • 00816576025213 ()
G193

  • Differential/selective agar culture medium IVD
Cetrimide Selective Agar, USP, 15x100mm Plate, 26ml. Hardy Diagnostics Cetrimide Selective Agar is recommended for the selective isolation and identification of Pseudomonas aeruginosa.
HARDY DIAGNOSTICS
G18
In Commercial Distribution

  • 00816576025183 ()
  • 00816576025190 ()
G18

  • Differential/selective agar culture medium IVD
BCYE Agar with CCVC, 15x100mm plate, 24ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G170
In Commercial Distribution

  • 00816576025169 ()
  • 00816576025176 ()
G170

  • Differential/selective agar culture medium IVD
BiGGY Agar, 15x100mm Plate, 18ml. Hardy Diagnsotics BiGGY Agar (Bismuth Sulfite Glucose Glycine Yeast Agar) is a selective and differential medium used in the isolation and presumptive identification of Candida spp.
HARDY DIAGNOSTICS
G17
In Commercial Distribution

  • 00816576025145 ()
  • 00816576025152 ()
G17

  • Differential/selective agar culture medium IVD
PDA with Fildes and Nafcillin, 15x100mm Plate, 19ml. Hardy Diagnostics Peptic Digest Agar (PDA) with Fildes and Nafcillin is an enrichment medium recommended for the selective isolation of Haemophilus species.
HARDY DIAGNOSTICS
G141
In Commercial Distribution

  • 00816576025046 ()
  • 00816576025053 ()
G141

  • Differential/selective agar culture medium IVD
Stanford Potato Agar (SPA), (Potato Dextrose Agar with Chloramphenicol) for the selective cultivation of fungi from mixed specimens 15x100mm plate, 10/pk
HARDY DIAGNOSTICS
W16
In Commercial Distribution

  • 00816576024957 ()
  • 00816576025022 ()
W16

  • Differential/selective agar culture medium IVD
MacConkey Agar with Sorbitol, Cefixime, and Tellurite, 15x100mm Plate, 18ml. Hardy Diagnostics MacConkey Agar with Sorbitol, Cefixime, and Tellurite (CT-SMAC) is used for the selective and differential isolation of enterohemorrhagic Escherichia coli O157.
HARDY DIAGNOSTICS
G129
In Commercial Distribution

  • 00816576025008 ()
  • 00816576025015 ()
G129

  • Differential/selective agar culture medium IVD
Casein Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Casein Agar is recommended for use as a medium for the differentiation of aerobic actinomycetes based on casein proteolysis. Organisms that can hydrolyse casein, such as Streptomyces, Pseudomonas, and Actinomadura spp. will produce a clear halo in the surrounding medium.
HARDY DIAGNOSTICS
G122
In Commercial Distribution

  • 00816576024964 ()
  • 00816576024971 ()
G122

  • Differential/selective agar culture medium IVD
SABHI Agar with Chloramphenicol & Gentamicin Slant, 10ml, order by the package of 20 (Sabouraud Dextrose Agar and Brain Heart Infusion Agar with Chloramphenicol and Gentamicin) For the selective isolation and cultivation of pathogenic fungi.
HARDY DIAGNOSTICS
L38
Not in Commercial Distribution

  • 00816576024650 ()
  • 00816576024940 ()
L38

  • Differential/selective agar culture medium IVD
Bile Esculin Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin Agar (BEA) is recommended for use as a differential medium in the isolation and presumptive identification of enterococci/group D streptococci.
HARDY DIAGNOSTICS
G12
In Commercial Distribution

  • 00816576024926 ()
  • 00816576024933 ()
G12

  • Differential/selective agar culture medium IVD
CGB Agar, 15x100mm Plate, 20ml. Hardy Diagnostics CGB Agar is recommended for the differentiation of Cryptococcus neoformans var. neoformans and Cryptococcus gattii (formerly C. neoformans var. gattii).
HARDY DIAGNOSTICS
G113
In Commercial Distribution

  • 00816576024902 ()
  • 00816576024919 ()
G113

  • Differential/selective agar culture medium IVD
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