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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™ - 00816576021048

Tobramycin 10μg (NN10) 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
Z9175
In Commercial Distribution

  • 00816576021048 ()
  • 00816576021796 ()
Z9175

  • Tobramycin susceptibility testing disc IVD

HardyDisk™ - 00816576021031

Tobramycin 10μg (NN10) 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
Z9171
In Commercial Distribution

  • 00816576021031 ()
  • 00816576021796 ()
Z9171

  • Tobramycin susceptibility testing disc IVD

HardyDisk™ - 00816576020997

Tetracycline 30μg (Te30) 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
Z9125
In Commercial Distribution

  • 00816576020997 ()
  • 00816576021765 ()
Z9125

  • Tetracycline susceptibility testing disc IVD

HardyDisk™ - 00816576020980

Tetracycline 30μg (Te30) 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
Z9121
In Commercial Distribution

  • 00816576020980 ()
  • 00816576021765 ()
Z9121

  • Tetracycline susceptibility testing disc IVD

HardyDisk™ - 00816576020959

Streptomycin 10μg (S10) 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
Z8995
Not in Commercial Distribution

  • 00816576020959 ()
  • 00816576021741 ()
Z8995

  • Streptomycin susceptibility testing disc IVD

HardyDisk™ - 00816576020942

Streptomycin 10μg (S10) 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
Z8991
In Commercial Distribution

  • 00816576020942 ()
  • 00816576021741 ()
Z8991

  • Streptomycin susceptibility testing disc IVD

HardyDisk™ - 00816576020911

Piperacillin 100μg (PIP100) 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
Z8905
In Commercial Distribution

  • 00816576020911 ()
  • 00816576021727 ()
Z8905

  • Piperacillin susceptibility testing disc IVD

HardyDisk™ - 00816576020898

Penicillin 10μg (P10) 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
Z8885
In Commercial Distribution

  • 00816576020898 ()
  • 00816576021710 ()
Z8885

  • Penicillin G susceptibility testing disc IVD

HardyDisk™ - 00816576020881

Penicillin 10μg (P10) 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
Z8881
In Commercial Distribution

  • 00816576020881 ()
  • 00816576021710 ()
Z8881

  • Penicillin G susceptibility testing disc IVD

HardyDisk™ - 00816576020874

Oxacillin 1μg (OX1) 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
Z8855
In Commercial Distribution

  • 00816576020874 ()
  • 00816576021703 ()
Z8855

  • Oxacillin susceptibility testing disc IVD
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