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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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EnteroScreen 4™, for Salmonella and Shigella screening, 11ml, 16x125mm tube, 4 layer slant, order by the package of 20 For the screening of enteric pathogens and the differentiation of Salmonella and Shigella from stool specimens and to rule out normal enteric flora. With this method, urease activity, lysine-decarboxylase, lysine-deaminase, gas production, and hydrogen sulfide production reactions can be simultaneously evaluated; all from one tube! Invented by Dr. Gary Procop of the Cleveland Clinic. See technical insert for color ID chart
HARDY DIAGNOSTICS
L225
In Commercial Distribution

  • 00819398022125 ()
  • 00819398022132 ()
L225

  • Differential/selective agar culture medium IVD
NaCl 6.5% Agar Slant, salt tolerance agar, 6.5ml, 16x100mm tube, order by the package of 20 (Brain Heart Infusion Agar with 6.5% NaCl without indicator, "Salt Tolerance Agar") For the identification of Enterococcus spp.
HARDY DIAGNOSTICS
L22
In Commercial Distribution

  • 00819398022101 ()
  • 00819398022118 ()
L22

  • Differential/selective agar culture medium IVD
Phenylalanine Agar Slant, 6.5ml, 16x100mm tube, order by the package of 20 For the differentiation of gram negative bacilli based on the production of phenylpyruvic acid by oxidative deamination. Use with ferric chloride 10% (cat no. Z63)
HARDY DIAGNOSTICS
L21
In Commercial Distribution

  • 00819398022088 ()
  • 00819398022095 ()
L21

  • Differential/selective agar culture medium IVD
Nutrient Agar Slant, 5.5ml, 16x100mm tube, order by the package of 20 For the cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
L20
In Commercial Distribution

  • 00819398022064 ()
  • 00819398022071 ()
L20

  • Basic/simple nutrient agar culture medium IVD
TSI (Triple Sugar Iron) Agar Slant, 6.0ml, 16x100mm tube, order by the package of 20 (Triple Sugar Iron Agar) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
L16
In Commercial Distribution

  • 00819398022040 ()
  • 00819398022057 ()
L16

  • Differential/selective agar culture medium IVD
Acetate Differential Slant, 16x100mm tube, order by the package of 20 For the differentiation of E. coli and Shigella spp.
HARDY DIAGNOSTICS
L15
In Commercial Distribution

  • 00819398022026 ()
  • 00819398022033 ()
L15

  • Differential/selective agar culture medium IVD
Caffeic Acid Agar Slant (Bird Seed Agar), for Cryptococcus, 16x100mm tube, order by the package of 20 For the selective isolation and differentiation of Cryptococcus neoformans and Cryptococcus gattii. Also known as Bird Seed Agar or Niger Seed Agar.
HARDY DIAGNOSTICS
L13
Not in Commercial Distribution

  • 00819398022002 ()
  • 00819398022019 ()
L13

  • Differential/selective agar culture medium IVD
Malt Extract Agar with 0.01% Chloramphenicol, Slant, 5.5ml, 16x100mm tube, order by the package of 20 (Malt Extract Agar with 0.01% Chloramphenicol) For the selective isolation of fungi.
HARDY DIAGNOSTICS
L128
In Commercial Distribution

  • 00819398021982 ()
  • 00819398021999 ()
L128

  • Differential/selective agar culture medium IVD
Blood Agar, 5%, Slant, 5.5ml, 16x100mm tube, order by the package of 20 (Tryptic Soy Agar with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
L12
In Commercial Distribution

  • 00819398021968 ()
  • 00819398021975 ()
L12

  • Basic/simple nutrient agar culture medium IVD
Nutrient Agar Slant, 5.5mL, 15x103mm tube, 20 tubes/box For the cultivation of non-fastidious microorganisms
HARDY DIAGNOSTICS
L117
Not in Commercial Distribution

  • 00819398021944 ()
  • 00819398021951 ()
L117

  • Basic/simple nutrient agar culture medium IVD
BHI (Brain Heart Infusion) Agar with Blood, Chloramphenicol and Gentamicin, 20x125mm tube, order by the package of 20 (Brain Heart Infusion Agar with 5% Sheep Blood, Chloramphenicol, and Gentamicin) For the selective isolation of fungi
HARDY DIAGNOSTICS
L114
In Commercial Distribution

  • 00819398021906 ()
  • 00819398021913 ()
L114

  • Differential/selective agar culture medium IVD
Bile Esculin Agar Slant, BEA, 16x100mm tube, 20 tubes/pack (Bile Esculin Agar) For the identification of group D streptococci including enterococci.
HARDY DIAGNOSTICS
L10
In Commercial Distribution

  • 00819398021883 ()
  • 00819398021890 ()
L10

  • Differential/selective agar culture medium IVD
Acetamide Agar Slant, for Pseudomonas, 16x100mm tube, order by the package of 20 For the selective isolation and identification of Pseudomonas aeruginosa.
HARDY DIAGNOSTICS
L02
In Commercial Distribution

  • 00819398021869 ()
  • 00819398021876 ()
L02

  • Differential/selective agar culture medium IVD
Arylsulfatase, 0.003M, for Mycobacteria, 16x125mm tube, 2ml, order by the package of 2 For use in detecting arylsulfatase production in slow-growing mycobacteria.
HARDY DIAGNOSTICS
K94
Not in Commercial Distribution

  • 00819398021845 ()
  • 00819398021852 ()
K94

  • Differential/selective broth culture medium IVD
Arylsulfatase, 0.001M, for Mycobacteria, 16x125mm tube, 2ml, order by the package of 20 For use in detecting arylsulfatase production in rapidly-growing mycobacteria.
HARDY DIAGNOSTICS
K93
In Commercial Distribution

  • 00819398021821 ()
  • 00819398021838 ()
K93

  • Differential/selective broth culture medium IVD
Tryptic Soy Broth (TSB), 5ml fill, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms.
HARDY DIAGNOSTICS
K89
In Commercial Distribution

  • 00819398021784 ()
  • 00819398021791 ()
K89

  • Basic/simple nutrient broth culture medium IVD
Tryptic Soy Broth (TSB), 9ml, 16x100mm tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms.
HARDY DIAGNOSTICS
K88
In Commercial Distribution

  • 00819398021760 ()
  • 00819398021777 ()
K88

  • Basic/simple nutrient broth culture medium IVD
Tryptic Soy Broth (TSB), filtered to remove dead bacteria, 1mL, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Tryptic Soy Broth) Filtered to remove non-viable organisms.
HARDY DIAGNOSTICS
K85
In Commercial Distribution

  • 00819398021746 ()
  • 00819398021753 ()
K85

  • Basic/simple nutrient broth culture medium IVD
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Rapid Ornithine, 1mL, 15x103mm tube, 20 tubes/pack For the rapid detection of ornithine decarboxylase activity in bacteria. To be used with Sterile Mineral Oil (Cat. no Z80)
HARDY DIAGNOSTICS
K279
In Commercial Distribution

  • 00819398021289 ()
  • 00819398021296 ()
K279

  • Differential/selective broth culture medium IVD
BHI Broth, 5mL, 15x103mm tube, 20 tubes/pack (Brain Heart Infusion Broth) For the cultivation of microorganism
HARDY DIAGNOSTICS
K27
In Commercial Distribution

  • 00819398021265 ()
  • 00819398021272 ()
K27

  • Basic/simple nutrient broth culture medium IVD
Jordan's Tartrate Agar,Deep 15x103mm tube, 20 tubes/pack For the differentiation of gram-negative organisms based on tartrate utilization.
HARDY DIAGNOSTICS
K26
In Commercial Distribution

  • 00819398021241 ()
  • 00819398021258 ()
K26

  • Differential/selective broth culture medium IVD
BHI Broth, 16x125mm tube, 20 tubes/pack (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
K25
In Commercial Distribution

  • 00819398021203 ()
  • 00819398021210 ()
K25

  • Basic/simple nutrient broth culture medium IVD
Thioglycollate with H and K (Hemin and Vitamin K), filtered (to remove dead bacteria), 10ml fill, 16x125mm tube, 20 tubes/pack For the cultivation of fastidious anaerobic bacteria. Filtered to remove all dead bacteria and debris.
HARDY DIAGNOSTICS
K24
In Commercial Distribution

  • 00819398021166 ()
  • 00819398021173 ()
K24

  • Basic/simple nutrient broth culture medium IVD
MR-VP, 2mL, 15x100mm tube, 20 tubes/pack (Methyl Red and Voges-Proskauer) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
K237
In Commercial Distribution

  • 00819398021142 ()
  • 00819398021159 ()
K237

  • Differential/selective broth culture medium IVD
Thioglycollate with Supplements, (Hemin, Vitamin K, and Calcium Carbonate Chip), 16x125mm tube, 20 tubes/box (Thioglycollate without indicator, with hemin, vitamin K, and calcium carbonate chip a a buffer) For the cultivation of bacteria including fastidious anaerobes. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K23
In Commercial Distribution

  • 00819398021104 ()
  • 00819398021111 ()
K23

  • Basic/simple nutrient broth culture medium IVD
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