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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HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies. HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca.
HARDY DIAGNOSTICS
J28
In Commercial Distribution

  • 00816576026838 ()
  • 00816576026845 ()
J28

  • Multiple formulation agar culture medium IVD
  • Multiple bacteria carbapenemase production IVD, kit, chromogenic
HardyCHROM™ MRSA/ HardyCHROM™ Staph aureus, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. HardyCHROM™ Staph aureus is a chromogenic medium recommended for the isolation, differentiation, and enumeration of Staphylococcus aureus by colony color
HARDY DIAGNOSTICS
J35
In Commercial Distribution

  • 00816576026791 ()
  • 00816576026807 ()
J35

  • Multiple formulation agar culture medium IVD
HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies.
HARDY DIAGNOSTICS
G323
In Commercial Distribution

  • 00816576025770 ()
  • 00816576025763 ()
G323

  • Multiple bacteria carbapenemase production IVD, kit, chromogenic
HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark.
HARDY DIAGNOSTICS
G321
In Commercial Distribution

  • 00816576023097 ()
  • 00816576023080 ()
G321

  • ESBL Enterobacteriaceae agar culture medium IVD, chromogenic
MRSA / VRE BIPLATE (Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with Vancomycin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococci.
HARDY DIAGNOSTICS
J112
Not in Commercial Distribution

  • 00816576020225 ()
  • 00816576021307 ()
J112

  • Multiple formulation 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
HTM AGAR (Haemophilus Test Medium) For disk diffusion sensitivity testing of Haemophilus spp.
HARDY DIAGNOSTICS
G33
In Commercial Distribution

  • 00816576020119 ()
  • 00816576021369 ()
G33

  • Haemophilus species antimicrobial susceptibility culture medium IVD
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
Selective and differential chromogenic medium for screening of rectal swabs for carbapenemase-producing Escherichia coli and Klebsiella pneumoniae.
BIOMERIEUX SA
CHROMID® CARBA agar
In Commercial Distribution

  • 03573026409913 ()
  • 03573026597719 ()
  • 03573026597726 ()


  • Differential/selective agar culture medium IVD
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