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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 - 00819398023313

NaCl 6.5% Broth without indicator, salt tolerance broth, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Salt Tolerance Broth without Indicator) For the identification of Enterococcus spp.
HARDY DIAGNOSTICS
R27
In Commercial Distribution

  • 00819398023306 ()
  • 00819398023313 ()
R27

  • Differential/selective broth culture medium IVD

N/A - 00819398023290

NaCl 6.5% Broth with indicator, salt tolerance broth, 1ml, 13x100mm 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
R26
In Commercial Distribution

  • 00819398023283 ()
  • 00819398023290 ()
R26

  • Differential/selective broth culture medium IVD

N/A - 00819398023276

MIO (Motility, Indole, and Ornithine Decarboxylase) Medium, 4.0ml, 13x100mm tube, order by the package of 20 For the determination of motility, indole, and ornithine decarboxylation of gram negative bacilli.
HARDY DIAGNOSTICS
R24
In Commercial Distribution

  • 00819398023269 ()
  • 00819398023276 ()
R24

  • Differential/selective broth culture medium IVD

N/A - 00819398023238

LIA (Lysine Iron Agar) Slant, 4.5ml, 13x100mm tube, order by the package of 20 (Lysine Iron Agar Slant) For the identification of gram negative enteric pathogens.
HARDY DIAGNOSTICS
R22
In Commercial Distribution

  • 00819398023221 ()
  • 00819398023238 ()
R22

  • Differential/selective agar culture medium IVD

N/A - 00819398023214

BiGGY Agar Slant (Nickerson's Agar), for Candida, 3ml, 13x100mm tube, order by the package of 20 For the selective isolation and identification of Candida spp.
HARDY DIAGNOSTICS
R21
In Commercial Distribution

  • 00819398023207 ()
  • 00819398023214 ()
R21

  • Differential/selective agar culture medium IVD

N/A - 00819398023177

BHI (Brain Heart Infusion) Broth, 5ml, 13x100mm tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
R20
In Commercial Distribution

  • 00819398023160 ()
  • 00819398023177 ()
R20

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023153

Brucella Broth, 13x100mm tube, 1ml, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics Brucella Broth is recommended for use as a general purpose growth media for the isolation, cultivation, and differentiation of a variety of fastidious organisms, such as Streptococcus and Brucella spp. in clinical and food samples.
HARDY DIAGNOSTICS
R18
In Commercial Distribution

  • 00819398023146 ()
  • 00819398023153 ()
R18

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023115

BHI (Brain Heart Infusion) Broth, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
R15
In Commercial Distribution

  • 00819398023108 ()
  • 00819398023115 ()
R15

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023092

Rapid Voges-Proskauer (VP test) 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the rapid detection of acetylmethylcarbinol (acetoin) in gram-negative bacteria.
HARDY DIAGNOSTICS
R14
In Commercial Distribution

  • 00819398023085 ()
  • 00819398023092 ()
R14

  • Differential/selective broth culture medium IVD

N/A - 00819398023078

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

N/A - 00819398023054

BHI (Brain Heart Infusion) Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
R10
Not in Commercial Distribution

  • 00819398023047 ()
  • 00819398023054 ()
R10

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023016

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

N/A - 00819398022996

Nutrient Agar, 20x150mm Tube, 20ml Deep, order by the package of 20 Hardy Diagnostics Nutrient Agar formulations are general purpose growth media recommended for use in the isolation and cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
Q65
Not in Commercial Distribution

  • 00819398022989 ()
  • 00819398022996 ()
Q65

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022972

MacConkey Agar Deep, 20x150mm tube, order by the package of 20 Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
HARDY DIAGNOSTICS
Q63
In Commercial Distribution

  • 00819398022965 ()
  • 00819398022972 ()
Q63

  • Differential/selective agar culture medium IVD

N/A - 00819398022934

Tryptic Soy Agar (TSA) Deep, USP, 18ml, 20x125mm pour tube, order by the package of 20 For use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance, and transportation of pure cultures of microorganisms
HARDY DIAGNOSTICS
Q58
In Commercial Distribution

  • 00819398022927 ()
  • 00819398022934 ()
Q58

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022910

Sabouraud Dextrose (SabDex) Agar with Chloramphenicol, 20x125mm glass tube, 18ml fill, order by the package of 20 Sabourauds Dextrose Agar with Chloramphenicol for the selective isolation of fungi.
HARDY DIAGNOSTICS
Q34
In Commercial Distribution

  • 00819398022903 ()
  • 00819398022910 ()
Q34

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022897

Regan-Lowe Semi Solid Agar Deep, for Bordetella pertussis, 4ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Charcoal Blood Agar with 10% Horse Blood and Cephalexin) For the selective isolation of Bordetella pertussis.
HARDY DIAGNOSTICS
Q32
In Commercial Distribution

  • 00819398022880 ()
  • 00819398022897 ()
Q32

  • Differential/selective agar culture medium IVD

N/A - 00819398022835

Potato Dextrose Agar Deep, USP, 18ml, 20x125mm pour tube, order by the package of 20 For the cultivation of yeasts and molds.
HARDY DIAGNOSTICS
Q29
In Commercial Distribution

  • 00819398022828 ()
  • 00819398022835 ()
Q29

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022798

Nutrient Gelatin Deep, 6ml, 15x103mm pour tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of the ability of bacteria to liquefy gelatin.
HARDY DIAGNOSTICS
Q23
In Commercial Distribution

  • 00819398022781 ()
  • 00819398022798 ()
Q23

  • Differential/selective agar culture medium IVD

N/A - 00819398022774

MIO (Motility, Indole, and Ornithine Decarboxylase) Medium, 6.5ml, 16x100mm tube, order by the package of 20 For the determination of motility, indole, and ornithine decarboxylation of gram negative bacilli.
HARDY DIAGNOSTICS
Q20
In Commercial Distribution

  • 00819398022767 ()
  • 00819398022774 ()
Q20

  • Differential/selective broth culture medium IVD

N/A - 00819398022750

BHI Agar, 20x150mm Tube, 18ml Deep, order by the package of 20 Hardy Diagnostics Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
HARDY DIAGNOSTICS
Q16
In Commercial Distribution

  • 00819398022743 ()
  • 00819398022750 ()
Q16

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022736

Corn Meal Agar with Tween® 80 Deep, for chlamydospores, 18ml deep, 20x125mm pour tube, order by the package of 20 For the cultivation of fungi. Induces chlamydospore formation by Candida spp.
HARDY DIAGNOSTICS
Q12
Not in Commercial Distribution

  • 00819398022729 ()
  • 00819398022736 ()
Q12

  • Differential/selective agar culture medium IVD

N/A - 00819398022712

Motility with TTC (Tetrazolium growth indicator) Medium, 8ml, 16x100mm tube, order by the package of 20 For the determination of motility in gram negative bacteria. Contains TTC growth indicator.
HARDY DIAGNOSTICS
Q11
In Commercial Distribution

  • 00819398022705 ()
  • 00819398022712 ()
Q11

  • Differential/selective broth culture medium IVD

N/A - 00819398022699

Motility Test Medium, 8ml, 16x100mm tube, order by the package of 20 Motility Test Medium with and without Triphenyltetrazolium Chloride (TTC) is recommended for the detection of motility in gram-negative enteric bacilli. TTC is added to enhance visualization of bacterial growth
HARDY DIAGNOSTICS
Q10
In Commercial Distribution

  • 00819398022682 ()
  • 00819398022699 ()
Q10

  • Differential/selective broth culture medium IVD

N/A - 00819398022675

MIL (Motility, Indole, Lysine deaminase, and decarboxylase) Medium, 8ml, 16x100mm tube, order by the package of 20 For the determination of motility, indole, lysine deamination, and lysine decarboxylation of gram negative bacilli.
HARDY DIAGNOSTICS
Q09
In Commercial Distribution

  • 00819398022668 ()
  • 00819398022675 ()
Q09

  • Differential/selective broth culture medium IVD

N/A - 00819398022651

Motility Test Agar, 16x100mm tube, 20 tubes/box For the detection of motility in gram-negative bacteria. Without TTC growth indicator.
HARDY DIAGNOSTICS
Q06
Not in Commercial Distribution

  • 00819398022644 ()
  • 00819398022651 ()
Q06

  • Differential/selective agar culture medium IVD

N/A - 00819398022637

Nutrient Agar, 18mL, 20x125mm tube, 20 tubes/box For the cultivation of non-fastidious microorganisms
HARDY DIAGNOSTICS
Q04
Not in Commercial Distribution

  • 00819398022620 ()
  • 00819398022637 ()
Q04

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022613

Agar Deep, 1.5%, (Water Agar), 16x125mm pour tube, 9ml Deep, order by the package of 20 Hardy Diagnostics Agar, 1.5% (Water Agar) is used in the Kirby-Bauer alternative agar-overlay method of inoculation for antimicrobial disk diffusion susceptibility testing and for microbiological procedures that require an additive-free solid medium, such as in performing colony counts, testing antimicrobial disk potency, or in performing the modified fungal slide culture method.
HARDY DIAGNOSTICS
Q01
In Commercial Distribution

  • 00819398022606 ()
  • 00819398022613 ()
Q01

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022590

Tech Agar, 5.5ml fill, 16x100mm tube slant, order by the package of 20 For the production of pyocyanin pigment by Pseudomonas species.
HARDY DIAGNOSTICS
L96
In Commercial Distribution

  • 00819398022583 ()
  • 00819398022590 ()
L96

  • Differential/selective agar culture medium IVD

N/A - 00819398022576

Nitrate Assimilation, Modified, 6ml fill, 16x125mm tube, order by the package of 20 For the determination of nitrate assimilation by yeasts.
HARDY DIAGNOSTICS
L95
Not in Commercial Distribution

  • 00819398022569 ()
  • 00819398022576 ()
L95

  • Differential/selective agar culture medium IVD

N/A - 00819398022552

Potato Dextrose Agar Slant, USP, 10ml, 20x125mm tube, order by the package of 20 For the cultivation of yeasts and molds.
HARDY DIAGNOSTICS
L90
In Commercial Distribution

  • 00819398022545 ()
  • 00819398022552 ()
L90

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022538

Simmons Citrate Agar Slant, 10ml, 16x100mm tube, order by the package of 20 For the detection of citrate utilization of gram negative enteric bacilli.
HARDY DIAGNOSTICS
L80
In Commercial Distribution

  • 00819398022521 ()
  • 00819398022538 ()
L80

  • Differential/selective agar culture medium IVD

N/A - 00819398022514

Dermatophyte Milk Agar, 6ml, 16x100mm tube, order by the package of 20 For the cultivation and differentiation of certain dermatophytes, especially Trichophyton rubrum, T. mentagrophytes, and Microsporum persicolor.
HARDY DIAGNOSTICS
L75
In Commercial Distribution

  • 00819398022507 ()
  • 00819398022514 ()
L75

  • Differential/selective agar culture medium IVD

N/A - 00819398022491

KIA (Kligler Iron Agar) Slant, 16x125mm tube, order by the package of 20 (Kligler Iron Agar) For the identification of gram negative enteric bacteria based on hydrogen sulfide production and the fermentation of dextrose and lactose.
HARDY DIAGNOSTICS
L70
In Commercial Distribution

  • 00819398022484 ()
  • 00819398022491 ()
L70

  • Differential/selective agar culture medium IVD

N/A - 00819398022477

Urea Agar Slant, 5.5ml, 16x100mm tube, order by the package of 20 (Christensen's Urea) For the detection of urease production in bacteria.
HARDY DIAGNOSTICS
L65
In Commercial Distribution

  • 00819398022460 ()
  • 00819398022477 ()
L65

  • Differential/selective agar culture medium IVD

N/A - 00819398022453

Tryptic Soy Agar (TSA) Slant, 5.5ml, 16x100mm tube, order by the package of 20 (Tryptic Soy Agar) For the cultivation of microorganisms. For use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance, and transportation of pure cultures of microorganisms.
HARDY DIAGNOSTICS
L60
In Commercial Distribution

  • 00819398022446 ()
  • 00819398022453 ()
L60

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022392

TSI (Triple Sugar Iron) Agar Slant, 8.0ml, 16x125mm tube, order by the package of 20 (Triple Sugar Iron Agar) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
L50
In Commercial Distribution

  • 00819398022385 ()
  • 00819398022392 ()
L50

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022378

Inhibitory Mold Agar with Gentamicin Slant, 10ml, 20x125mm tube, order by the package of 20 (Inhibitory Mold Agar with Gentamicin) For the selective isolation of pathogenic fungi.
HARDY DIAGNOSTICS
L49
In Commercial Distribution

  • 00819398022361 ()
  • 00819398022378 ()
L49

  • Differential/selective agar culture medium IVD

N/A - 00819398022354

Inhibitory Mold Agar Slant (with chloramphenicol), 10ml, 20x125mm tube, order by the package of 20 For the selective isolation of pathogenic fungi. Contains chloramphenicol for inhibition of bactieria.
HARDY DIAGNOSTICS
L47
In Commercial Distribution

  • 00819398022347 ()
  • 00819398022354 ()
L47

  • Differential/selective agar culture medium IVD

N/A - 00819398022330

Mycobiotic Agar Slant, 10ml, 20x125mm tube, order by the package of 20 For the selective isolation of pathogenic fungi especially from hair, skin, and nail specimens. Contains chloramphenicol and cyclohexamide.
HARDY DIAGNOSTICS
L45
In Commercial Distribution

  • 00819398022323 ()
  • 00819398022330 ()
L45

  • Differential/selective agar culture medium IVD

N/A - 00819398022316

Sabdex (Sabouraud Dextrose) Agar Slant, 10ml, 20x125mm tube, order by the package of 20 (Sabourauds Dextrose Agar) For the cultivation of fungi.
HARDY DIAGNOSTICS
L40
In Commercial Distribution

  • 00819398022309 ()
  • 00819398022316 ()
L40

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022279

BHI (Brain Heart Infusion) Agar Slant, 5.5ml fill, 16x100mm tube, order by the package of 20 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
L36
In Commercial Distribution

  • 00819398022262 ()
  • 00819398022279 ()
L36

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022255

BHI (Brain Heart Infusion) Agar Slant, 20x125mm tube, order by the package of 20 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
L35
In Commercial Distribution

  • 00819398022248 ()
  • 00819398022255 ()
L35

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022231

BHI (Brain Heart Infusion) Agar with Blood Slant, 20x125mm tube, order by the package of 20 (Brain Heart Infusion Agar with 5% Sheep Blood) For the cultivation of fungi.
HARDY DIAGNOSTICS
L31
In Commercial Distribution

  • 00819398022224 ()
  • 00819398022231 ()
L31

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398022217

Esculin Agar Slant, 6.5ml fill, 16x100mm tube, order by the package of 20 For the determination of esculin hydrolysis by bacteria, such as group D streptococci, Fusobacterium spp.and Bacteroides spp.
HARDY DIAGNOSTICS
L29
In Commercial Distribution

  • 00819398022200 ()
  • 00819398022217 ()
L29

  • Differential/selective agar culture medium IVD

N/A - 00819398022170

DTM (Dermatophyte Test Media) Agar Slant, 7.5ml Slant, order by the package of 20 (Dermatophyte Test Medium) For the isolation and identification of dermatophytic fungi such as Microsporum canis, the causative agent of ringworm. It is also designed to detect dermatophytes such as Epidermophyton and Trichophyton spp. The addition of Gentamicin and Chlortetracycline act as broad spectrum antimicrobics to inhibit a wide range of interfering gram-positive and gram-negative bacteria. Cycloheximide is added to inhibit saprophytic non-pathogenic fungi. Phenol red, the pH indicator, is affected by the presence of dermatophytes (Epidermophyton, Microsporum, and Trichophyton spp.), which all produce alkaline metabolites. Vials are made of shatter resistant polycarbonate plastic with a wide mouth opening for easy inoculatio
HARDY DIAGNOSTICS
L27
In Commercial Distribution

  • 00819398022163 ()
  • 00819398022170 ()
L27

  • Differential/selective agar culture medium IVD

N/A - 00819398022156

LIA (Lysine Iron Agar) Slant, 8ml, 16x125mm tube, order by the package of 20 (Lysine Iron Agar Slant) For the identification of gram negative enteric pathogens.
HARDY DIAGNOSTICS
L25
In Commercial Distribution

  • 00819398022149 ()
  • 00819398022156 ()
L25

  • Differential/selective agar culture medium IVD

N/A - 00819398022132

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

N/A - 00819398022118

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

N/A - 00819398022095

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
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