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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 - 00816576026609

Thioglycollate w/o Indicator, 10mL,16x125mm tube,10 tubes/box. For the cultivation of microorganisms. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
6020
Not in Commercial Distribution

  • 00816576026463 ()
  • 00816576026609 ()
6020

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026593

Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective and differential medium used for the isolation and differentiation of gram-negative enteric pathogens. Hardy Diagnostics SS Agar is recommended for use as a selective and differential medium for the isolation of Salmonella and some Shigella species from clinical and non-clinical specimens.
HARDY DIAGNOSTICS
J139
Not in Commercial Distribution

  • 00816576026586 ()
  • 00816576026593 ()
J139

  • Multiple formulation agar culture medium IVD

N/A - 00816576026579

Arcano Select / Group A Beta Strep Biplate, 15x100mm Plate, 10ml/10ml. Hardy Diagnostics Arcanobacterium Selective Agar is recommended for use as a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J134
Not in Commercial Distribution

  • 00816576026562 ()
  • 00816576026579 ()
J134

  • Multiple formulation 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 - 00816576026456

BHI (Brain Heart Infusion) Agar Slant, 16x125mm tube, order by the package of 10 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
6007
Not in Commercial Distribution

  • 00816576026449 ()
  • 00816576026456 ()
6007

  • Basic/simple nutrient 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 - 00816576026425

TSA / TSA, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Tryptic Soy Agar is recommended 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
J108
Not in Commercial Distribution

  • 00816576026418 ()
  • 00816576026425 ()
J108

  • Basic/simple nutrient 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
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