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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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Columbia Blood Agar, 15x100 monoplate, 10/pk (Columbia Agar Base with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A16
In Commercial Distribution

  • 00816576023905 ()
  • 00816576023912 ()
A16

  • Enriched agar culture medium IVD
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
Horse Blood Agar 5%, 15x100mm Plate, 17ml. Hardy Diagnostics Horse Blood Agar is an enriched all-purpose growth medium recommended for the cultivation of nonfastidious and fastidious microorganisms such as Haemophilus spp.
HARDY DIAGNOSTICS
A149
In Commercial Distribution

  • 00816576023868 ()
  • 00816576023875 ()
A149

  • Enriched agar culture medium IVD
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
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
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
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
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
Blood Agar Plate, 15x100, 10pks of 10 (Tryptic Soy Agar with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A10BX
In Commercial Distribution

  • 00816576023738 ()
  • 00816576023752 ()
A10BX

  • Enriched agar culture medium IVD
Blood Agar, 5%, 15x100, 10/pk (Tryptic Soy Agar with 5% Sheep Blood) For the cultivation of microorganisms
HARDY DIAGNOSTICS
A10
In Commercial Distribution

  • 00816576023738 ()
  • 00816576023745 ()
A10

  • Enriched agar culture medium IVD
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