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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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ONPG-PDA, for rapid lactose fermentation and phenylalanine deaminase detection, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 To aid in the rapid identification of Salmonella and Shigella spp. in clinical specimens. Detects beta-galactosidase and phenylalanine deaminase activity.
HARDY DIAGNOSTICS
R93
In Commercial Distribution

  • 00819398023740 ()
  • 00819398023757 ()
R93

  • Differential/selective broth culture medium IVD
ONPG, Rapid Test Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the rapid determination of beta-Galactosidase activity of gram negative bacilli.
HARDY DIAGNOSTICS
R92
In Commercial Distribution

  • 00819398023726 ()
  • 00819398023733 ()
R92

  • Differential/selective broth culture medium IVD
PPLO Selective Broth, 4ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the selective isolation of Mycoplasmataceae (pleural pneumonia-like organisms), especially Mycoplasma pneumoniae.
HARDY DIAGNOSTICS
R88
In Commercial Distribution

  • 00819398023702 ()
  • 00819398023719 ()
R88

  • Differential/selective broth culture medium IVD
SP4 Broth with Urea, for Mycoplasma and Ureaplasma, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the selective cultivation and differentiation of mycoplasmas; including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
HARDY DIAGNOSTICS
R87
In Commercial Distribution

  • 00819398023689 ()
  • 00819398023696 ()
R87

  • Differential/selective broth culture medium IVD
SP4 Broth with Glucose, for Mycoplasma and Ureaplasma, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 2 For the selective cultivation and differentiation of the mycoplasmas; including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
HARDY DIAGNOSTICS
R86
In Commercial Distribution

  • 00819398023665 ()
  • 00819398023672 ()
R86

  • Differential/selective broth culture medium IVD
PPLO Broth, for Mycoplasma pneumoniae, 5ml, 13x100mm tube, order by the package of 20 For the cultivation and maintenance of mycoplasmas.
HARDY DIAGNOSTICS
R80
Not in Commercial Distribution

  • 00819398023627 ()
  • 00819398023634 ()
R80

  • Differential/selective broth culture medium IVD
Tryptic Soy Broth (TSB), 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth.
HARDY DIAGNOSTICS
R41
In Commercial Distribution

  • 00819398023443 ()
  • 00819398023450 ()
R41

  • Basic/simple nutrient broth culture medium IVD
Tryptic Soy Broth (TSB), USP, 1ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
R36
In Commercial Distribution

  • 00819398023405 ()
  • 00819398023412 ()
R36

  • Basic/simple nutrient broth culture medium IVD
Koser Citrate Broth, 4ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the differentiation of Escherichia coli from Enterobacter aerogenes based on citrate utilization. This broth is used primarily for coliform determinations from water and wastewater samples.
HARDY DIAGNOSTICS
R135
Not in Commercial Distribution

  • 00819398023061 ()
  • 00819398023078 ()
R135

  • Differential/selective broth culture medium IVD
Nutrient Agar, 20x150mm Tube, 20ml Deep, order by the package of 100, Hardy Diagnostics Nutrient Agar formulations are general purpose growth media recommended for use in the isolation and cultivation of nonfastidious microorganisms.
HARDY DIAGNOSTICS
Q84
Not in Commercial Distribution

  • 00819398023009 ()
  • 00819398023016 ()
Q84

  • Basic/simple nutrient agar culture medium IVD
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