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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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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
Acanthamoeba Broth, 15x103mm Tube, 5ml. Hardy Diagnostics Acanthamoeba Broth, also known as Peptone-Yeast Extract-Glucose (PYG) Medium, is recommended for the maintenance of Acanthamoeba stock cultures.
HARDY DIAGNOSTICS
K225
In Commercial Distribution

  • 00819398021081 ()
  • 00819398021098 ()
K225

  • Differential/selective broth culture medium IVD
Thioglycollate with H & K, 16x100mm Tube, 5ml. Hardy Diagnostics Thioglycollate Media is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms.
HARDY DIAGNOSTICS
K22
In Commercial Distribution

  • 00819398021067 ()
  • 00819398021074 ()
K22

  • Enriched broth culture medium IVD
Cooked Meat Medium, 20x125mm Tube, 15ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
K219
In Commercial Distribution

  • 00819398021043 ()
  • 00819398021050 ()
K219

  • Enriched broth culture medium IVD
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
MacConkey Broth, 10mL, 16x125mm tube, 20 tubes/box For the detection of gram-negative, lactose fermenting bacilli. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
K194
In Commercial Distribution

  • 00819398021005 ()
  • 00819398021012 ()
K194

  • Differential/selective broth culture medium IVD
Cooked Meat Medium, 16x125mm Tube, 10ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
K19
In Commercial Distribution

  • 00819398020985 ()
  • 00819398020992 ()
K19

  • Enriched broth culture medium IVD
Hippurate Disks, 25 disks/jar. Hippurate disks are used for the sodium hippurate hydrolysis test. Glycine, an end product of hippurate hydrolysis, reacts with ninhydrin to produce a purple color. Hippurate is commonly used to presumptively identify Gardnerella vaginalis, Listeria monocytogenes, Campylobacter jejuni and group B streptococci.
HARDY DIAGNOSTICS
Z18
In Commercial Distribution

  • 00819398020930 ()
  • 00819398020947 ()
Z18

  • Hippurate hydrolase microbial reagent IVD
Buffered Yeast Extract, 16x125mm Tube, 10mL. Hardy Diagnostics Buffered Yeast Extract (BYE) broth is recommended for use in the cultivation of Legionella spp. in water and other samples suspected of harboring the bacteria.
HARDY DIAGNOSTICS
K159
Not in Commercial Distribution

  • 00819398020909 ()
  • 00819398020916 ()
K159

  • Enriched broth culture medium IVD
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
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