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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 - 00816576027125

Haemophilus ID Quadplate, for Haemophilus ID Quadplate consists of four separate formulations, which supply the requirements as follows: RTF Casman Medium, Modified (X- and V-factors) Tryptic Soy Agar (TSA) with Hemin (X-factor) Tryptic Soy Agar (TSA), modified with NAD (V-factor) Chocolate Agar (X- and V-factors) For the differentiation of Haemophilus spp.X and V Factors, 15x100mm quadplate, order by the package of 10
HARDY DIAGNOSTICS
J82
In Commercial Distribution

  • 00816576027118 ()
  • 00816576027125 ()
J82

  • Differential/selective agar culture medium IVD

N/A - 00816576026999

MacConkey Agar / EMB Agar, Levine, 15x100mm Biplate, 10ml/10ml. 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 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
J58
In Commercial Distribution

  • 00816576026982 ()
  • 00816576026999 ()
J58

  • 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 - 00816576026906

Corn Meal with Tween® 80, 15x100mm Biplate, 13ml/13ml. Hardy Diagnostics 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
J48
Not in Commercial Distribution

  • 00816576026890 ()
  • 00816576026906 ()
J48

  • Differential/selective agar culture medium IVD

N/A - 00816576026500

MacConkey/MacConkey Biplate 15x100 biplate, 10/pk (MacConkey Agar) For the isolation and differentiation of gram-negative bacteria. Some ingredients are very light sensitive. Store and incubate media in the dark
HARDY DIAGNOSTICS
J118
In Commercial Distribution

  • 00816576026494 ()
  • 00816576026500 ()
J118

  • Differential/selective agar culture medium IVD

N/A - 00816576026432

Bile Esculin Agar Slant, BEA, 16x125mm tube, 10 tubes/pack (Bile Esculin Agar) For the identification of group D streptococci including enterococci.
HARDY DIAGNOSTICS
6001
Not in Commercial Distribution

  • 00816576026371 ()
  • 00816576026432 ()
6001

  • Differential/selective agar culture medium IVD

N/A - 00816576026364

BiGGY Agar Slant (Nickerson's Agar), 6ml, 16x125mm tube, order by the package of 10 For the selective isolation and identification of Candida spp.
HARDY DIAGNOSTICS
6000
In Commercial Distribution

  • 00816576026333 ()
  • 00816576026364 ()
6000

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576026357

HUrBi™, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ HUrBi™ Biplate is a selective chromogenic medium recommended for the cultivation, differentiation and enumeration of various gram-negative and gram-positive bacteria, and yeast based on colony color and morphology. Selective agents have been added to the each side of the biplate to select for growth of gram-positive organisms and yeast on one side and to select for growth of gram-negative organisms on the other side of the biplate.
HARDY DIAGNOSTICS
J100
In Commercial Distribution

  • 00816576026340 ()
  • 00816576026357 ()
J100

  • Differential/selective agar culture medium IVD

N/A - 00816576026326

Middlebrook 7H11 Selective Agar, 15x100mm Biplate, 16ml/16ml. Hardy Diagnostics Middlebrook 7H11 Agar is recommended for use in the selective isolation of Mycobacterium species. Some ingredients are very light sensitive. Store and incubate media in the dark.
HARDY DIAGNOSTICS
J31
In Commercial Distribution

  • 00816576026074 ()
  • 00816576026326 ()
J31

  • Differential/selective 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
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