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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 - 00816576027347

BHI (Brain Heart Infusion) Agar, deep fill, 15x100mm plate, order by the package of 10 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
W15
In Commercial Distribution

  • 00816576027330 ()
  • 00816576027347 ()
W15

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027323

BCYE Agar with VPC, 15x100mm plate, order by the package of 10 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
HARDY DIAGNOSTICS
W79
In Commercial Distribution

  • 00816576027316 ()
  • 00816576027323 ()
W79

  • Differential/selective agar culture medium IVD

N/A - 00816576027309

Czapek Yeast Agar, deep fill, 15x100mm, order by the package of 10 For the isolation and cultivation of yeasts.
HARDY DIAGNOSTICS
W117
Not in Commercial Distribution

  • 00816576027293 ()
  • 00816576027309 ()
W117

  • Differential/selective agar culture medium IVD

N/A - 00816576027286

Corn Meal Agar with Tween® 80, for chlamydospores, deep fill, 15x100mm plate, order by the package of 10 Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.
HARDY DIAGNOSTICS
W10
In Commercial Distribution

  • 00816576027279 ()
  • 00816576027286 ()
W10

  • Differential/selective agar culture medium IVD

N/A - 00816576026968

G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other microorganisms found in the female genitourinary tract.
HARDY DIAGNOSTICS
G367
In Commercial Distribution

  • 00816576026951 ()
  • 00816576026968 ()
G367

  • Differential/selective agar culture medium IVD

N/A - 00816576026920

CIN Agar / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
J49
In Commercial Distribution

  • 00816576026913 ()
  • 00816576026920 ()
J49

  • Multiple formulation agar culture medium IVD

N/A - 00816576026630

Bile Esculin Agar / Sodium Chloride (NaCl) 6.5% without Indicator, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bile Esculin Agar (BEA) is recommended for use as a differential medium in the isolation and presumptive identification of enterococci/group D streptococci. Hardy Diagnostics NaCl 6.5% Media are recommended for use in salt tolerance testing to differentiate Enterococcus from non-enterococcal group D streptococci.
HARDY DIAGNOSTICS
J165
Not in Commercial Distribution

  • 00816576026623 ()
  • 00816576026630 ()
J165

  • Multiple formulation agar culture medium IVD

N/A - 00816576026258

Group A Beta Strep Agar, 15x100mm Plate, Reduced Stacking Ring, 17ml. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
GA72
In Commercial Distribution

  • 00816576026241 ()
  • 00816576026258 ()
GA72

  • Differential/selective agar culture medium IVD

N/A - 00816576026234

Columbia CNA Agar, 15x100mm Plate, 19ml (reduced stacking ring). Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
GA50
In Commercial Distribution

  • 00816576026227 ()
  • 00816576026234 ()
GA50

  • Differential/selective agar culture medium IVD

N/A - 00816576026210

MacConkey Agar, 15x100mm Plate, 19ml (reduced stacking ring). 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
GA35
In Commercial Distribution

  • 00816576026203 ()
  • 00816576026210 ()
GA35

  • Differential/selective agar culture medium IVD
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