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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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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

N/A - 00819398021395

Litmus Milk, 5mL, 15x103mm tube, 20 tubes/box For the determination of bacterial action upon milk
HARDY DIAGNOSTICS
K34
In Commercial Distribution

  • 00819398021388 ()
  • 00819398021395 ()
K34

  • Differential/selective broth culture medium IVD

N/A - 00819398021371

FB Broth, 10mL, 16x125mm tube, 20 tubes/box (Fastidious Bacteria Broth) For the enriched cultivation of neisseria, haemophilus, streptococcus, corynebacteria and other fastidious bacteria from clinical specimens.
HARDY DIAGNOSTICS
K31
In Commercial Distribution

  • 00819398021364 ()
  • 00819398021371 ()
K31

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021357

Thioglycollate w/o Indicator, 10mL, 16x125mm tube, 20 tubes/box For the cultivation of microorganisms. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K29
In Commercial Distribution

  • 00819398021340 ()
  • 00819398021357 ()
K29

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021333

TSB, Filtered, 2mL, 15x103mm tube, 20 tubes/pack (Tryptic Soy Broth) For use as a general purpose medium for the cultivation of a wide variety of bacteria and fungi.
HARDY DIAGNOSTICS
K285
In Commercial Distribution

  • 00819398021326 ()
  • 00819398021333 ()
K285

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021319

Thio with supplements, 15mL, 20x125mm tube, 20 tubes/pack (Thioglycollate without indicator, with hemin, vitamin K, and calcium carbonate chip as a buffer) For the cultivation of anaerobes and other fastidious bacteria. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K28
In Commercial Distribution

  • 00819398021302 ()
  • 00819398021319 ()
K28

  • Basic/simple nutrient broth culture medium IVD
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