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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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Ceftaroline 30μg (CPT30) 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
Z9391
In Commercial Distribution

  • 00816576021918 ()
  • 00816576021932 ()
Z9391

  • Multiple antibacterial susceptibility profile kit IVD
Doripenem 10μg (DOR10) 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
Z9371
In Commercial Distribution

  • 00816576021857 ()
  • 00816576021871 ()
Z9371

  • Multiple antibacterial susceptibility profile kit IVD
Tigecycline 15μg (TGC15) 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
Z9361
In Commercial Distribution

  • 00816576021109 ()
  • 00816576021833 ()
Z9361

  • Tigecycline susceptibility testing disc IVD
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity 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 many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9245
In Commercial Distribution

  • 00816576021086 ()
  • 00816576021819 ()
Z9245

  • Vancomycin susceptibility testing disc IVD
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity 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 many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9241
In Commercial Distribution

  • 00816576021079 ()
  • 00816576021819 ()
Z9241

  • Vancomycin susceptibility testing disc IVD
Trimethoprim 5μg (TMP5) 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
Z9181
In Commercial Distribution

  • 00816576021055 ()
  • 00816576021802 ()
Z9181

  • Trimethoprim susceptibility testing disc IVD
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
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
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
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
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