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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 - 00816576024353

PEA with 5% Sheep Blood, 15x100mm Plate, 18ml. Hardy Diagnostics PEA with 5% Sheep Blood is a selective medium recommended for the isolation of gram-positive microorganisms, particularly gram-positive cocci, from mixed specimens.
HARDY DIAGNOSTICS
A93
In Commercial Distribution

  • 00816576024346 ()
  • 00816576024353 ()
A93

  • Differential/selective agar culture medium IVD

N/A - 00816576024339

Anaerobic PEA, 15x100mm Plate, 18ml. Hardy Diagnostics Anaerobic PEA Agar is recommended for use as an enriched medium for the cultivation and selective isolation of gram-positive and negative obligate anaerobic bacteria.
HARDY DIAGNOSTICS
A90
In Commercial Distribution

  • 00816576024322 ()
  • 00816576024339 ()
A90

  • Differential/selective agar culture medium IVD

N/A - 00816576024278

Group A Beta Strep Agar, 15x100mm Plate, 17ml Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
A72
In Commercial Distribution

  • 00816576024261 ()
  • 00816576024278 ()
A72

  • Differential/selective agar culture medium IVD

N/A - 00816576024193

Rose Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Rose Agar is recommended for use as a selective growth medium for the cultivation and isolation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
A66
In Commercial Distribution

  • 00816576024186 ()
  • 00816576024193 ()
A66

  • Differential/selective agar culture medium IVD

N/A - 00816576024179

Regan-Lowe Agar, 15x100mm Plate, 22ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A65
In Commercial Distribution

  • 00816576024162 ()
  • 00816576024179 ()
A65

  • Differential/selective agar culture medium IVD

N/A - 00816576024155

Regan-Lowe Agar without Cephalexin, 15x100mm Plate, 24ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A63
In Commercial Distribution

  • 00816576024148 ()
  • 00816576024155 ()
A63

  • Differential/selective agar culture medium IVD

N/A - 00816576024131

Neomycin Anaerobic Blood Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Neomycin Anaerobic Agar is recommended for use in the primary isolation of fastidious anaerobic microorganisms.
HARDY DIAGNOSTICS
A62
In Commercial Distribution

  • 00816576024124 ()
  • 00816576024131 ()
A62

  • Differential/selective agar culture medium IVD

N/A - 00816576024117

LKV Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
HARDY DIAGNOSTICS
A60
In Commercial Distribution

  • 00816576024100 ()
  • 00816576024117 ()
A60

  • Differential/selective agar culture medium IVD

N/A - 00816576024094

Columbia CNA, 15x100 monoplate, 10/pks of 10 (Columbia Agar with 5% Sheep Blood, Colistin, and Nalidixic Acid) For the selective isolation of gram positive bacteria.
HARDY DIAGNOSTICS
A50BX
In Commercial Distribution

  • 00816576024070 ()
  • 00816576024094 ()
A50BX

  • Differential/selective agar culture medium IVD

N/A - 00816576024087

Columbia CNA, 15x100 monoplate, 10/pk (Columbia Agar with 5% Sheep Blood, Colistin, and Nalidixic Acid) For the selective isolation of gram positive bacteria.
HARDY DIAGNOSTICS
A50
In Commercial Distribution

  • 00816576024070 ()
  • 00816576024087 ()
A50

  • Differential/selective agar culture medium IVD

N/A - 00816576024063

Campy CVA Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Campy CVA Agar Plates are recommended for the selective isolation of Campylobacter species from fecal specimens.
HARDY DIAGNOSTICS
A40
In Commercial Distribution

  • 00816576024056 ()
  • 00816576024063 ()
A40

  • Differential/selective agar culture medium IVD

N/A - 00816576024049

GBS Detect, 15x100 monoplate, 10pks of 10 For the isolation and differentiation by enhanced hemolysis of gamma hemolytic Group B Streptococcus
HARDY DIAGNOSTICS
A300BX
In Commercial Distribution

  • 00816576024025 ()
  • 00816576024049 ()
A300BX

  • Differential/selective agar culture medium IVD

N/A - 00816576024032

GBS Detect, 15x100 monoplate, 10/pk For the isolation and differentiation by enhanced hemolysis of gamma hemolytic group B Streptococcus.
HARDY DIAGNOSTICS
A300
In Commercial Distribution

  • 00816576024025 ()
  • 00816576024032 ()
A300

  • Differential/selective broth culture medium IVD

N/A - 00816576023899

StrePlate™, 15x100mm Monoplate, 22ml. Hardy Diagnostics' Bacti-Lab StrePlate™ is on enriched media for the selective isolation of all Streptococcus spp., including beta-hemolytic group A (Streptococcus pyogenes), group B (Streptococcus agalactiae), groups C, D, F and G; and Streptococcus pneumoniae.
HARDY DIAGNOSTICS
A150
In Commercial Distribution

  • 00816576023882 ()
  • 00816576023899 ()
A150

  • Differential/selective agar culture medium IVD

N/A - 00816576023851

Campy FDA Agar, 15x100, 10/pk (Campylobacter FDA Agar with amphotericin, novobiocin, polymyxin, trimethoprim, and vancomycin). For the isolation and cultivation of Campylobacter spp.
HARDY DIAGNOSTICS
A139
In Commercial Distribution

  • 00816576023844 ()
  • 00816576023851 ()
A139

  • Differential/selective agar culture medium IVD

N/A - 00816576023837

Campylobacter Blood Agar, 15x100mm plate, 18ml. Hardy Diagnostics Campylobacter Blood Agar is recommended for the primary isolation and cultivation of Campylobacter jejuni from human fecal specimens.
HARDY DIAGNOSTICS
A137
In Commercial Distribution

  • 00816576023820 ()
  • 00816576023837 ()
A137

  • Differential/selective agar culture medium IVD

N/A - 00816576023813

Arcanobacterium Selective Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Arcanobacterium Selective Agar is recommended for use as a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens.
HARDY DIAGNOSTICS
A134
Not in Commercial Distribution

  • 00816576023806 ()
  • 00816576023813 ()
A134

  • Differential/selective agar culture medium IVD

N/A - 00816576023790

Campy Cefex Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Campy Cefex Agar, Modified plates are recommended for the selective isolation of cephalothin-resistant Campylobacter species such as C. jejuni , C. coli , and C. lari from human, animal, or food samples.
HARDY DIAGNOSTICS
A122
In Commercial Distribution

  • 00816576023783 ()
  • 00816576023790 ()
A122

  • Differential/selective agar culture medium IVD

N/A - 00816576023776

Blood Agar with Ampicillin, 15x100mm Plate, 17ml. Hardy Diagnostics Blood Agar with Ampicillin is recommended for the cultivation and selective isolation of Aeromonas spp.
HARDY DIAGNOSTICS
A12
In Commercial Distribution

  • 00816576023769 ()
  • 00816576023776 ()
A12

  • Differential/selective agar culture medium IVD

N/A - 00816576023547

Potato Dextrose Agar, 15x100, 10/pk For the cultivation of yeasts and molds.
HARDY DIAGNOSTICS
1052
Not in Commercial Distribution

  • 00816576023530 ()
  • 00816576023547 ()
1052

  • Basic/simple nutrient agar culture medium IVD
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