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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 - 00819398021296

Rapid Ornithine, 1mL, 15x103mm tube, 20 tubes/pack For the rapid detection of ornithine decarboxylase activity in bacteria. To be used with Sterile Mineral Oil (Cat. no Z80)
HARDY DIAGNOSTICS
K279
In Commercial Distribution

  • 00819398021289 ()
  • 00819398021296 ()
K279

  • Differential/selective broth culture medium IVD

N/A - 00819398021272

BHI Broth, 5mL, 15x103mm tube, 20 tubes/pack (Brain Heart Infusion Broth) For the cultivation of microorganism
HARDY DIAGNOSTICS
K27
In Commercial Distribution

  • 00819398021265 ()
  • 00819398021272 ()
K27

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021258

Jordan's Tartrate Agar,Deep 15x103mm tube, 20 tubes/pack For the differentiation of gram-negative organisms based on tartrate utilization.
HARDY DIAGNOSTICS
K26
In Commercial Distribution

  • 00819398021241 ()
  • 00819398021258 ()
K26

  • Differential/selective broth culture medium IVD

N/A - 00819398021210

BHI Broth, 16x125mm tube, 20 tubes/pack (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
K25
In Commercial Distribution

  • 00819398021203 ()
  • 00819398021210 ()
K25

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021173

Thioglycollate with H and K (Hemin and Vitamin K), filtered (to remove dead bacteria), 10ml fill, 16x125mm tube, 20 tubes/pack For the cultivation of fastidious anaerobic bacteria. Filtered to remove all dead bacteria and debris.
HARDY DIAGNOSTICS
K24
In Commercial Distribution

  • 00819398021166 ()
  • 00819398021173 ()
K24

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021159

MR-VP, 2mL, 15x100mm tube, 20 tubes/pack (Methyl Red and Voges-Proskauer) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
K237
In Commercial Distribution

  • 00819398021142 ()
  • 00819398021159 ()
K237

  • Differential/selective broth culture medium IVD

N/A - 00819398021111

Thioglycollate with Supplements, (Hemin, Vitamin K, and Calcium Carbonate Chip), 16x125mm tube, 20 tubes/box (Thioglycollate without indicator, with hemin, vitamin K, and calcium carbonate chip a a buffer) For the cultivation of bacteria including fastidious anaerobes. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K23
In Commercial Distribution

  • 00819398021104 ()
  • 00819398021111 ()
K23

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021036

Thioglycollate with Indicator, 16x125mm Tube, 10ml. Hardy Diagnostics Thioglycollate Media is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms.
HARDY DIAGNOSTICS
K21
In Commercial Distribution

  • 00819398021029 ()
  • 00819398021036 ()
K21

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398020893

Pyrazinamidase Agar, 16x125mm Tube, 5ml Deep. Hardy Diagnostics Pyrazinamidase Agar is used to differentiate Mycobacterium species on the basis of pyrazinamidase activity.
HARDY DIAGNOSTICS
K158
Not in Commercial Distribution

  • 00819398020886 ()
  • 00819398020893 ()
K158

  • Differential/selective agar culture medium IVD

N/A - 00819398020879

MR-VP Broth, 5mL, 15x103mm tube, 20 tubes/box (Methyl Red and Voges-Proskauer) For the identification of gram negative bacilli
HARDY DIAGNOSTICS
K156
Not in Commercial Distribution

  • 00819398020862 ()
  • 00819398020879 ()
K156

  • Differential/selective broth culture medium IVD
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