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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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Modified Oxford Medium, 15x100 monoplate, 10/pk (Oxford Listeria Agar) For the selective isolation and differentiation of Listeria monocytogenes
HARDY DIAGNOSTICS
GA46
Not in Commercial Distribution

  • 00816576027064 ()
  • 00816576028511 ()
GA46

  • Differential/selective agar culture medium IVD
MEA with Chloramphenicol ,15x100 monoplate 10/pk For the isolation, cultivation, and enumeration of yeast and mold.
HARDY DIAGNOSTICS
W92
In Commercial Distribution

  • 00816576028177 ()
  • 00816576028184 ()
W92

  • Differential/selective agar culture medium IVD
HardyCHROM™ Salmonella / XLT-4 Agar, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ Salmonella is a chromogenic medium recommended for the selective isolation and differentiation of Salmonella spp. from other members of the family Enterobacteriaceae based on colony color. Hardy Diagnostics XLT-4 Agar is a highly selective plating medium for the detection and isolation of non-typhi Salmonella species.
HARDY DIAGNOSTICS
J37
In Commercial Distribution

  • 00816576028139 ()
  • 00816576028146 ()
J37

  • Multiple formulation agar culture medium IVD
GBS Detect™, 15x100mm Plate, 17ml (reduced stacking ring). Hardy Diagnostics GBS Detect™ is recommended for the isolation and differentiation by enhanced hemolysis of detection of gamma-hemolytic (non-hemolytic) Group B Streptococcus from GBS enrichment broth procedures.
HARDY DIAGNOSTICS
GA300
In Commercial Distribution

  • 00816576028016 ()
  • 00816576028023 ()
GA300

  • Differential/selective agar culture medium IVD
Burkholderia cepacia Selective Agar (BCSA), USP, 15x100mm Plate, 18ml (reduced staking ring). Hardy Diagnostics Burkholderia cepacia Selective Agar (BCSA), USP is recommended for the selective isolation and differentiation of Burkholderia cepacia from sputum samples from cystic fibrosis patients and other clinical specimens. In addition, the medium complies with the U.S. Pharmacopoeia <60> for the Microbial Examination of Non-sterile Products–Tests for Burkholderia cepacia complex.
HARDY DIAGNOSTICS
GA09
In Commercial Distribution

  • 00816576027996 ()
  • 00816576028009 ()
GA09

  • Differential/selective agar culture medium IVD
Liver Infusion Agar Selective, 15x100mm plate, order by the package of 10 (Liver Infusion Selective Agar with Polymyxin B, Nalidixic acid and Vancomycin) For the selective isolation of fungi.
HARDY DIAGNOSTICS
W95
In Commercial Distribution

  • 00816576027958 ()
  • 00816576027965 ()
W95

  • Differential/selective agar culture medium IVD
Potato Dextrose Agar with Chloramphenicol, 15x100mm plate, 28ml fill, order by the package of 100 Recommended for the selective cultivation of fungi from mixed samples.
HARDY DIAGNOSTICS
W94BX
In Commercial Distribution

  • 00816576027927 ()
  • 00816576027934 ()
W94BX

  • Differential/selective agar culture medium IVD
Malt Extract Agar with 0.01% Chloramphenicol, deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of fungi.
HARDY DIAGNOSTICS
W80
In Commercial Distribution

  • 00816576027880 ()
  • 00816576027897 ()
W80

  • Differential/selective agar culture medium IVD
SabHI Agar, (Sabdex and Brain Heart Infusion) deep fill, 15x100mm plate, order by the package of 10 For the cultivation of fungi. A combination of Sabouraud Dextrose and Brain Heart Infusion Agar.
HARDY DIAGNOSTICS
W75
In Commercial Distribution

  • 00816576027866 ()
  • 00816576027873 ()
W75

  • Basic/simple nutrient agar culture medium IVD
Sabdex (Sabouraud Dextrose) Agar with Chloramphenicol and Tetracycline, deep fill, 15x100mm plate, order by the package of 10 (Sabouraud Dextrose Agar with Chloramphenicol and Tetracycline) For the selective isolation of fungi.
HARDY DIAGNOSTICS
W74
In Commercial Distribution

  • 00816576027842 ()
  • 00816576027859 ()
W74

  • Differential/selective agar culture medium IVD
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