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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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HardyDisk™ - 00816576020515

Ceftriaxone 30μg (CRO30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8315
In Commercial Distribution

  • 00816576020515 ()
  • 00816576021499 ()
Z8315

  • Ceftriaxone susceptibility testing disc IVD

HardyDisk™ - 00816576020508

Ceftriaxone 30μg (CRO30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8311
In Commercial Distribution

  • 00816576020508 ()
  • 00816576021499 ()
Z8311

  • Ceftriaxone susceptibility testing disc IVD

HardyDisk™ - 00816576020492

Ceftazidime 30μg (CAZ30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8275
In Commercial Distribution

  • 00816576020492 ()
  • 00816576021482 ()
Z8275

  • Ceftazidime susceptibility testing disc IVD

HardyDisk™ - 00816576020485

Ceftazidime 30μg (CAZ30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8271
In Commercial Distribution

  • 00816576020485 ()
  • 00816576021482 ()
Z8271

  • Ceftazidime susceptibility testing disc IVD

HardyDisk™ - 00816576020454

Cefotetan 30μg (CTT30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8235
In Commercial Distribution

  • 00816576020454 ()
  • 00816576021468 ()
Z8235

  • Cefotetan susceptibility testing disc IVD

HardyDisk™ - 00816576020447

Cefotaxime 30μg (CTX30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8225
In Commercial Distribution

  • 00816576020447 ()
  • 00816576021451 ()
Z8225

  • Cefotaxime susceptibility testing disc IVD

HardyDisk™ - 00816576020430

Cefotaxime 30μg (CTX30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (KirbyBauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8221
In Commercial Distribution

  • 00816576020430 ()
  • 00816576021451 ()
Z8221

  • Cefotaxime susceptibility testing disc IVD

HardyDisk™ - 00816576020423

Cefazolin 30μg (CZ30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (KirbyBauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8145
In Commercial Distribution

  • 00816576020423 ()
  • 00816576021444 ()
Z8145

  • Cefazolin susceptibility testing disc IVD (obsolete)

HardyDisk™ - 00816576020409

Ceflacor 30μg (CEC30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (KirbyBauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8121
In Commercial Distribution

  • 00816576020409 ()
  • 00816576021437 ()
Z8121

  • Cefaclor susceptibility testing disc IVD

HardyDisk™ - 00816576020393

Carbenicillin 100μg (CB100) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8115
In Commercial Distribution

  • 00816576020393 ()
  • 00816576021420 ()
Z8115

  • Carbenicillin susceptibility testing disc IVD
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