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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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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

N/A - 00816576025534

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

N/A - 00816576025237

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

N/A - 00816576025213

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

N/A - 00816576025190

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

N/A - 00816576025176

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

N/A - 00816576025152

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

N/A - 00816576025053

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

N/A - 00816576025022

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
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