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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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Amikacin 30μg (AN30) 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
Z8011
In Commercial Distribution

  • 00816576020294 ()
  • 00816576021390 ()
Z8011

  • Amikacin susceptibility testing disc IVD
CHOCOLATE / MTM BIPLATE (Section I: Chocolate Agar; Section II: Thayer Martin, Modified) For the isolation of Neisseria gonorrhoeae.
HARDY DIAGNOSTICS
J72
In Commercial Distribution

  • 00816576020201 ()
  • 00816576021321 ()
J72

  • Thayer-Martin Neisseria species agar culture medium IVD
  • Basic chocolate agar culture medium IVD
CHOC. / M.L. with LINCO. BIPLATE (Chocolate Agar / Martin Lewis with Lincomycin). A biplate for the cultivation and isolation of Neisseria gonorrhoeae.
HARDY DIAGNOSTICS
J44
In Commercial Distribution

  • 00816576020195 ()
  • 00816576021338 ()
J44

  • Thayer-Martin Neisseria species agar culture medium IVD
  • Basic chocolate agar culture medium IVD
HardyCHROM™ MRSA A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE.
HARDY DIAGNOSTICS
G307
In Commercial Distribution

  • 00816576020140 ()
  • 00816576021239 ()
G307

  • MRSA agar culture medium IVD, chromogenic
MRSA SCREEN PLATE (Mueller Hinton with 4% NaCl and Oxacillin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus.
HARDY DIAGNOSTICS
G47
In Commercial Distribution

  • 00816576020126 ()
  • 00816576021284 ()
G47

  • MRSA agar culture medium IVD, selective antimicrobial
BHI AGAR with VANCOMYCIN (Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For detecting vancomycin resistant Enterococcus spp. (VRE).
HARDY DIAGNOSTICS
G14
In Commercial Distribution

  • 00816576020102 ()
  • 00816576021215 ()
G14

  • VRE/HLARE agar culture medium IVD
HardyCHROM™ MRSA - RSR A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE.
HARDY DIAGNOSTICS
GA307
In Commercial Distribution

  • 00816576020096 ()
  • 00816576021246 ()
GA307

  • MRSA agar culture medium IVD, chromogenic
MARTIN LEWIS with LINCOMYCIN (Martin Lewis Agar with lincomycin, reduced vancomycin, colistin, amphotericin, and trimethoprim) For the selective isolation of Neisseria gonorrhoeae.
HARDY DIAGNOSTICS
E39
In Commercial Distribution

  • 00816576020065 ()
  • 00816576021345 ()
E39

  • Thayer-Martin Neisseria species agar culture medium IVD
MARTIN LEWIS w/ LINCOMYCIN, PP (Martin Lewis Agar with lincomycin, reduced vancomycin, colistin, amphotericin, and trimethoprim) For the selective isolation of Neisseria gonorrhoeae. Petri plate has a "pill pocket" receptacle for the addition of a CO2 tablet. 10 tablets and 10 ziplock.
HARDY DIAGNOSTICS
E31
In Commercial Distribution

  • 00816576020058 ()
  • 00816576021208 ()
E31

  • Thayer-Martin Neisseria species agar culture medium IVD
MODIFIED THAYER MARTIN For the selective isolation of Neisseria gonorrhoeae. Contains vancomycin, colistin, nystatin, and trimethoprim antimicrobials.
HARDY DIAGNOSTICS
E30
In Commercial Distribution

  • 00816576020041 ()
  • 00816576021222 ()
E30

  • Thayer-Martin Neisseria species agar culture medium IVD
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