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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 - 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
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