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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 Class Implantable

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N/A - 00819398021739

Todd Hewitt Broth, 5ml, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the cultivation of Streptococcus spp. for serological typing.
HARDY DIAGNOSTICS
K79
In Commercial Distribution

  • 00819398021722 ()
  • 00819398021739 ()
K79

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021654

Selenite Cystine Broth, 16x125mm tube, order by the package of 20 For the selective enrichment of Salmonella spp. Cystine enhances growth of Salmonella spp.
HARDY DIAGNOSTICS
K69
In Commercial Distribution

  • 00819398021647 ()
  • 00819398021654 ()
K69

  • Differential/selective broth culture medium IVD

N/A - 00819398021609

BHI Broth, 4mL, 100 tubes/pack (Brain Heart Infusion Broth) For the cultivation of fastidious and nonfastidious microorganisms.
HARDY DIAGNOSTICS
R63BX
Not in Commercial Distribution

  • 00819398021593 ()
  • 00819398021609 ()
R63BX

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021579

Sabdex (Sabouraud Dextrose) Broth, 10ml, 16x125mm tube, order by the package of 20 For the cultivation of fungi
HARDY DIAGNOSTICS
K54
In Commercial Distribution

  • 00819398021562 ()
  • 00819398021579 ()
K54

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021531

NaCl 6.5% Broth with indicator, salt tolerance broth, 2mL, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20, (Salt Tolerance Broth with BCP indicator) For the identification of Enterococcus spp.
HARDY DIAGNOSTICS
K49
In Commercial Distribution

  • 00819398021524 ()
  • 00819398021531 ()
K49

  • Differential/selective broth culture medium IVD

N/A - 00819398021517

SF Broth, 5mL, 16x125mm tube, 20 tubes/box For the differentiation of group D enterococci from group D non-enterococci from milk, water, waste water, and fecal specimens.
HARDY DIAGNOSTICS
K45
In Commercial Distribution

  • 00819398021500 ()
  • 00819398021517 ()
K45

  • Differential/selective broth culture medium IVD

N/A - 00819398021494

Nutrient Broth, 5mL, 15x103mm tube, 20 tubes/box For the cultivation of non-fastidious microorganisms
HARDY DIAGNOSTICS
K43
In Commercial Distribution

  • 00819398021487 ()
  • 00819398021494 ()
K43

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021456

GN Broth, 10mL, 16x125mm tube, 20 tubes/box For the selective enrichment of salmonella and shigella in stool specimens
HARDY DIAGNOSTICS
K39
In Commercial Distribution

  • 00819398021449 ()
  • 00819398021456 ()
K39

  • Differential/selective broth culture medium IVD

N/A - 00819398021432

NR-VP Broth, 5mL, 15x103mm tube,20 tubes/pack (Methyl Red - Voges Proskauer) For the identification of gram negative bacilli
HARDY DIAGNOSTICS
K37
In Commercial Distribution

  • 00819398021425 ()
  • 00819398021432 ()
K37

  • Differential/selective broth culture medium IVD

N/A - 00819398021418

Malonate Broth, 5mL, 15x103mm tube, 20 tubes/pack For the differentiation of gram negative bacilli based on malonate utilization.
HARDY DIAGNOSTICS
K36
In Commercial Distribution

  • 00819398021401 ()
  • 00819398021418 ()
K36

  • Differential/selective broth culture medium IVD
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