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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 - 00816576024377

Schaedler's Agar with H&K, 15x100, monoplate, 10/pk (Schaedler's Agar with Hemin, Vitamin K, and 5% Sheep Blood) For the cultivation of anaerobic bacteria.
HARDY DIAGNOSTICS
A98
In Commercial Distribution

  • 00816576024360 ()
  • 00816576024377 ()
A98

  • Enriched agar culture medium IVD

N/A - 00816576024254

Blood Agar 10%, 15x100mm Plate, 18ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
A71
In Commercial Distribution

  • 00816576024247 ()
  • 00816576024254 ()
A71

  • Enriched agar culture medium IVD

N/A - 10819398028209

Blood Agar 5%, 86x128mm Omni Tray, 30ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
A127
In Commercial Distribution

  • 00819398028202 ()
  • 10819398028209 ()
A127

  • Enriched agar culture medium IVD

N/A - 00819398028431

PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per pack Differentiation and isolation of gram-negative and gram-positive organisms (as well as fermenting characteristics), preventing of Proteus swarming, differentiation of gram-positive organisms, early detector of yeast (growth on both PEA & T7 with white colonies).
HARDY DIAGNOSTICS
J120
In Commercial Distribution

  • 00819398028028 ()
  • 00819398028431 ()
J120

  • Multiple formulation agar culture medium IVD

N/A - 00816576028108

Blood Agar 5% / CLED Agar with Bile, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.
HARDY DIAGNOSTICS
J65
In Commercial Distribution

  • 00816576028092 ()
  • 00816576028108 ()
J65

  • Multiple formulation agar culture medium IVD

N/A - 00816576027224

Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J92
Not in Commercial Distribution

  • 00816576027217 ()
  • 00816576027224 ()
J92

  • Multiple formulation agar culture medium IVD

N/A - 00816576027187

Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pk For the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576027170 ()
  • 00816576027187 ()
J87

  • Multiple formulation agar culture medium IVD

N/A - 00816576026753

Blood Agar / CLED Agar / MacConkey Agar, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
HARDY DIAGNOSTICS
J315
In Commercial Distribution

  • 00816576026746 ()
  • 00816576026753 ()
J315

  • Multiple formulation agar culture medium IVD

N/A - 00816576026739

Blood Agar 5% / Eosin Methylene Blue (EMB), Levine Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
J22
In Commercial Distribution

  • 00816576026722 ()
  • 00816576026739 ()
J22

  • Multiple formulation agar culture medium IVD

N/A - 00816576026654

V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Starch Agar with Bromcresol Purple is recommended for use in the differentiation of Gardnerella vaginalis from genitourinary specimens. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
HARDY DIAGNOSTICS
J181
Not in Commercial Distribution

  • 00816576026647 ()
  • 00816576026654 ()
J181

  • Multiple formulation agar culture medium IVD
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