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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 - 00819398024808

Purple Broth with Mannitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y110
In Commercial Distribution

  • 00819398024792 ()
  • 00819398024808 ()
Y110

  • Differential/selective broth culture medium IVD

N/A - 00819398024785

CTA (Cystine Tryptic Agar) Base Medium (control), 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar, Base) A control tube for fermentation testing of bacteria.
HARDY DIAGNOSTICS
Y11
In Commercial Distribution

  • 00819398024778 ()
  • 00819398024785 ()
Y11

  • Differential/selective agar culture medium IVD

N/A - 00819398024761

Purple Broth with Maltose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y109
Not in Commercial Distribution

  • 00819398024754 ()
  • 00819398024761 ()
Y109

  • Differential/selective broth culture medium IVD

N/A - 00819398024747

Purple Broth with Lactose, 10ml fill, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y108
Not in Commercial Distribution

  • 00819398024730 ()
  • 00819398024747 ()
Y108

  • Differential/selective broth culture medium IVD

N/A - 00819398024723

Purple Broth with Inositol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y106
Not in Commercial Distribution

  • 00819398024716 ()
  • 00819398024723 ()
Y106

  • Differential/selective broth culture medium IVD

N/A - 00819398024709

Purple Broth with Dulcitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y105
Not in Commercial Distribution

  • 00819398024693 ()
  • 00819398024709 ()
Y105

  • Differential/selective broth culture medium IVD

N/A - 00819398024686

Purple Broth with Dextrose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y104
Not in Commercial Distribution

  • 00819398024679 ()
  • 00819398024686 ()
Y104

  • Differential/selective broth culture medium IVD

N/A - 00819398024662

Purple Broth with Cellobiose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y103
Not in Commercial Distribution

  • 00819398024655 ()
  • 00819398024662 ()
Y103

  • Differential/selective broth culture medium IVD

N/A - 00819398024648

Purple Broth with Arabinose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y102
Not in Commercial Distribution

  • 00819398024631 ()
  • 00819398024648 ()
Y102

  • Differential/selective broth culture medium IVD

N/A - 00819398024624

Purple Broth with Adonitol, 10mL, 16x125mm tube, 20 tubes/box For the differentiation of microorganisms based on acidification of carbohydrates or other compounds.
HARDY DIAGNOSTICS
Y101
Not in Commercial Distribution

  • 00819398024617 ()
  • 00819398024624 ()
Y101

  • Differential/selective broth culture medium IVD

N/A - 00819398024600

Purple Broth Base (control), 9ml, 16x125mm tube with durham tube, order by the package of 20 A control tube for the fermentation of carbohydrates.
HARDY DIAGNOSTICS
Y100
In Commercial Distribution

  • 00819398024594 ()
  • 00819398024600 ()
Y100

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398024587

CTA (Cystine Tryptic Agar) with Cellobiose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the determination of carbohydrate fermentation by fastidious organisms, such as Neisseria spp. It is also used for the detection of bacterial motility and serves as a culture media for microorganism maintenance.
HARDY DIAGNOSTICS
Y10
Not in Commercial Distribution

  • 00819398024570 ()
  • 00819398024587 ()
Y10

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024549

SabHI Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 For the cultivation of fungi. A combination of Sabouraud Dextrose and Brain Heart Infusion Agar.
HARDY DIAGNOSTICS
X75
In Commercial Distribution

  • 00819398024532 ()
  • 00819398024549 ()
X75

  • Basic/simple nutrient agar culture medium IVD

HardyFlask™ - 00819398024525

SabHI Agar with Blood, Chloramphenicol and Cycloheximide, 12ml, HardyFlask™, order by the package of 20 (Sabouraud Dextrose and Brain Heart Infusion Agar with 5% sheep blood, chloramphenicol and cycloheximide) For the selective isolation of pathogenic fungi.
HARDY DIAGNOSTICS
X73
In Commercial Distribution

  • 00819398024518 ()
  • 00819398024525 ()
X73

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024488

Potato Flake Selective Agar (with Cipro and Vanco), 12ml, 50ml plastic HardyFlask™, order by the package of 20 For the selective isolation of pathogenic fungi. Contains ciprofloxacin and vancomycin for the inhibition of most bacteria.
HARDY DIAGNOSTICS
X59
In Commercial Distribution

  • 00819398024471 ()
  • 00819398024488 ()
X59

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024464

Emmon's Sabdex (Sabouraud Dextrose) Agar, plastic HardyFlask™, order by the package of 20 Emmon's Sabdex Agar is recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts.
HARDY DIAGNOSTICS
X57
In Commercial Distribution

  • 00819398024457 ()
  • 00819398024464 ()
X57

  • Basic/simple nutrient agar culture medium IVD

HardyFlask™ - 00819398024365

Sabdex (Sabouraud Dextrose) Agar with Chloramphenicol, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Sabouraud Dextrose Agar with Chloramphenicol is recommended for the selective isolation of fungi and yeasts from clinical and nonclinical specimens
HARDY DIAGNOSTICS
X41
In Commercial Distribution

  • 00819398024358 ()
  • 00819398024365 ()
X41

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024341

Sabdex (Sabouraud Dextrose) Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts.
HARDY DIAGNOSTICS
X40
In Commercial Distribution

  • 00819398024334 ()
  • 00819398024341 ()
X40

  • Basic/simple nutrient agar culture medium IVD

HardyFlask™ - 00819398024327

Potato Flake Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Potato Flake Media is used in the cultivation, isolation, and induction of sporulation of fungi from clinical specimens.
HARDY DIAGNOSTICS
X32
In Commercial Distribution

  • 00819398024310 ()
  • 00819398024327 ()
X32

  • Basic/simple nutrient agar culture medium IVD

HardyFlask™ - 00819398024280

Mycobiotic Agar, 12ml fill, 50ml plastic HardyFlask™, 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
X30
In Commercial Distribution

  • 00819398024273 ()
  • 00819398024280 ()
X30

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024204

LJ (Lowenstein Jensen) Gruft, 50ml plastic HardyFlask™, order by the package of 20 Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
X23
In Commercial Distribution

  • 00819398024198 ()
  • 00819398024204 ()
X23

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024181

LJ (Lowenstein Jensen) Media, 50ml plastic HardyFlask™, order by the package of 20 Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
X22
In Commercial Distribution

  • 00819398024174 ()
  • 00819398024181 ()
X22

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024167

LJ (Lowenstein Jensen) with Ferric Ammonium Citrate, 50ml plastic HardyFlask™, order by the package of 20 (Lowenstein Jensen with Ferric Ammonium Citrate) For the cultivation of Mycobacterium spp.
HARDY DIAGNOSTICS
X21
In Commercial Distribution

  • 00819398024150 ()
  • 00819398024167 ()
X21

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024143

Inhibitory Mold Agar (with Chloramphenicol), plastic HardyFlask™, order by the package of 20 Inhibitory Mold Agar and Inhibitory Mold Agar with Gentamicin are recommended for the selective isolation of fungi.
HARDY DIAGNOSTICS
X20
In Commercial Distribution

  • 00819398024136 ()
  • 00819398024143 ()
X20

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024129

LJ (Lowenstein Jensen) with Pyruvate, 50ml plastic HardyFlask™, order by the package of 20 Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
X19
In Commercial Distribution

  • 00819398024112 ()
  • 00819398024129 ()
X19

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024105

DTM (Dermatophyte Test Medium) Agar, plastic HardyFlask™, order by the package of 20 Dermatophyte Test Medium (DTM) is a selective and differential medium recommended for the cultivation and isolation of pathogenic dermatophytic fungi.
HARDY DIAGNOSTICS
X15
In Commercial Distribution

  • 00819398024099 ()
  • 00819398024105 ()
X15

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024082

BHI (Brain Heart Infusion) Agar with Blood, Chloramphenicol and Gentamicin, plastic HardyFlask™, order by the package of 20 (Brain Heart Infusion Agar with 5% Sheep Blood, Chloramphenicol, and Gentamicin) For the selective isolation of pathogenic fungi.
HARDY DIAGNOSTICS
X14
In Commercial Distribution

  • 00819398024075 ()
  • 00819398024082 ()
X14

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024068

BHI (Brain Heart Infusion) Agar with Blood, plastic HardyFlask™, order by the package of 20 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. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi.
HARDY DIAGNOSTICS
X13
In Commercial Distribution

  • 00819398024051 ()
  • 00819398024068 ()
X13

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024044

BHI (Brain Heart Infusion) Agar with Blood and Gentamicin, plastic HardyFlask™, order by the package of 20 (Brian Heart Infusion Agar with 5% Sheep Blood and Gentamicin) For the selective isolation of pathogenic fungi.
HARDY DIAGNOSTICS
X12
In Commercial Distribution

  • 00819398024037 ()
  • 00819398024044 ()
X12

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024020

BHI (Brain Heart Infusion) Agar with Chloramphenicol and Cycloheximide, plastic HardyFlask™, order by the package of 20 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. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi.
HARDY DIAGNOSTICS
X11
In Commercial Distribution

  • 00819398024013 ()
  • 00819398024020 ()
X11

  • Differential/selective agar culture medium IVD

HardyFlask™ - 00819398024006

BHI (Brain Heart Infusion) Agar, plastic HardyFlask™, order by the package of 20 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. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi
HARDY DIAGNOSTICS
X10
In Commercial Distribution

  • 00819398023993 ()
  • 00819398024006 ()
X10

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398023924

LJ with Iron, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
C37
In Commercial Distribution

  • 00819398023917 ()
  • 00819398023924 ()
C37

  • Differential/selective broth culture medium IVD

N/A - 00819398023832

TSI Agar Slant (Triple Sugar Iron), with slip cap, 10ml, 16x125mm Round Bottom Tube, no label on container, order by the package of 100 For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
S15
In Commercial Distribution

  • 00819398023825 ()
  • 00819398023832 ()
S15

  • Differential/selective agar culture medium IVD

N/A - 00819398023795

Nitrate Substrate Broth, 2.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the determination of nitrate reactions of mycobacteria. Use with AFB nitrate reagents (cat. no. Z124 and Z125)
HARDY DIAGNOSTICS
R97
In Commercial Distribution

  • 00819398023788 ()
  • 00819398023795 ()
R97

  • Differential/selective broth culture medium IVD

N/A - 00819398023757

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

N/A - 00819398023733

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

N/A - 00819398023719

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

N/A - 00819398023696

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

N/A - 00819398023672

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

N/A - 00819398023658

SP4 Broth with Arginine, 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 the mycoplasmas; including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
HARDY DIAGNOSTICS
R85
In Commercial Distribution

  • 00819398023641 ()
  • 00819398023658 ()
R85

  • Differential/selective broth culture medium IVD

N/A - 00819398023634

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

N/A - 00819398023597

FB Broth, 13x85mm tube, 4ml fill, order by the package of 100 Recommend for use in the enriched cultivation of Neisseria, Haemophilus, Streptococcus, Corynebacteria and other fastidious bacteria from clinical specimens.
HARDY DIAGNOSTICS
R75BX
In Commercial Distribution

  • 00819398023580 ()
  • 00819398023597 ()
R75BX

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023573

KIA (Kligler Iron Agar) Slant, 13x100mm tube, 4.5ml fill, 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
R70
In Commercial Distribution

  • 00819398023566 ()
  • 00819398023573 ()
R70

  • Differential/selective agar culture medium IVD

N/A - 00819398023474

Urea Agar Slant, 3ml, 13x100mm tube, order by the package of 20 (Christensen's Urea) For the detection of urease production in bacteria.
HARDY DIAGNOSTICS
R42
In Commercial Distribution

  • 00819398023467 ()
  • 00819398023474 ()
R42

  • Differential/selective agar culture medium IVD

N/A - 00819398023450

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

NA - 00819398023436

Tryptone Broth 2%, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the performance of the Indole test. Use with Kovacs Reagent (cat. no. Z67).
HARDY DIAGNOSTICS
R40
In Commercial Distribution

  • 00819398023429 ()
  • 00819398023436 ()
R40

  • Differential/selective broth culture medium IVD

N/A - 00819398023412

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

N/A - 00819398023399

TSI (Triple Sugar Iron) Agar Slant, 4ml, 13x100mm tube, order by the package of 20 (Triple Sugar Iron Agar) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
R32
In Commercial Distribution

  • 00819398023382 ()
  • 00819398023399 ()
R32

  • Differential/selective agar culture medium IVD

N/A - 00819398023375

Tryptic Soy Broth (TSB), 2ml, 13x100mm tube, optically clear, Glass tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms.
HARDY DIAGNOSTICS
R31
In Commercial Distribution

  • 00819398023368 ()
  • 00819398023375 ()
R31

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398023351

Tryptic Soy Broth (TSB), 5ml fill, 13x100mm tube, order by the package of 20 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms.
HARDY DIAGNOSTICS
R30
In Commercial Distribution

  • 00819398023344 ()
  • 00819398023351 ()
R30

  • Basic/simple nutrient broth culture medium IVD
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