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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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BHI (Brain Heart Infusion) Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
R10
Not in Commercial Distribution

  • 00819398023047 ()
  • 00819398023054 ()
R10

  • Basic/simple nutrient broth culture medium IVD
Nutrient Agar, 20x150mm Tube, 20ml Deep, order by the package of 100, Hardy Diagnostics Nutrient Agar formulations are general purpose growth media recommended for use in the isolation and cultivation of nonfastidious microorganisms.
HARDY DIAGNOSTICS
Q84
Not in Commercial Distribution

  • 00819398023009 ()
  • 00819398023016 ()
Q84

  • Basic/simple nutrient agar culture medium IVD
Nutrient Agar, 20x150mm Tube, 20ml Deep, order by the package of 20 Hardy Diagnostics Nutrient Agar formulations are general purpose growth media recommended for use in the isolation and cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
Q65
Not in Commercial Distribution

  • 00819398022989 ()
  • 00819398022996 ()
Q65

  • Basic/simple nutrient agar culture medium IVD
MacConkey Agar Deep, 20x150mm tube, order by the package of 20 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
Q63
In Commercial Distribution

  • 00819398022965 ()
  • 00819398022972 ()
Q63

  • Differential/selective agar culture medium IVD
Tryptic Soy Agar (TSA) Deep, USP, 18ml, 20x125mm pour tube, order by the package of 20 For use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance, and transportation of pure cultures of microorganisms
HARDY DIAGNOSTICS
Q58
In Commercial Distribution

  • 00819398022927 ()
  • 00819398022934 ()
Q58

  • Basic/simple nutrient agar culture medium IVD
Sabouraud Dextrose (SabDex) Agar with Chloramphenicol, 20x125mm glass tube, 18ml fill, order by the package of 20 Sabourauds Dextrose Agar with Chloramphenicol for the selective isolation of fungi.
HARDY DIAGNOSTICS
Q34
In Commercial Distribution

  • 00819398022903 ()
  • 00819398022910 ()
Q34

  • Basic/simple nutrient agar culture medium IVD
Regan-Lowe Semi Solid Agar Deep, for Bordetella pertussis, 4ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Charcoal Blood Agar with 10% Horse Blood and Cephalexin) For the selective isolation of Bordetella pertussis.
HARDY DIAGNOSTICS
Q32
In Commercial Distribution

  • 00819398022880 ()
  • 00819398022897 ()
Q32

  • Differential/selective agar culture medium IVD
Potato Dextrose Agar Deep, USP, 18ml, 20x125mm pour tube, order by the package of 20 For the cultivation of yeasts and molds.
HARDY DIAGNOSTICS
Q29
In Commercial Distribution

  • 00819398022828 ()
  • 00819398022835 ()
Q29

  • Basic/simple nutrient agar culture medium IVD
Nutrient Gelatin Deep, 6ml, 15x103mm pour tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of the ability of bacteria to liquefy gelatin.
HARDY DIAGNOSTICS
Q23
In Commercial Distribution

  • 00819398022781 ()
  • 00819398022798 ()
Q23

  • Differential/selective agar culture medium IVD
MIO (Motility, Indole, and Ornithine Decarboxylase) Medium, 6.5ml, 16x100mm tube, order by the package of 20 For the determination of motility, indole, and ornithine decarboxylation of gram negative bacilli.
HARDY DIAGNOSTICS
Q20
In Commercial Distribution

  • 00819398022767 ()
  • 00819398022774 ()
Q20

  • Differential/selective broth culture medium IVD
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