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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 - 00816576027286

Corn Meal Agar with Tween® 80, for chlamydospores, deep fill, 15x100mm plate, order by the package of 10 Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.
HARDY DIAGNOSTICS
W10
In Commercial Distribution

  • 00816576027279 ()
  • 00816576027286 ()
W10

  • Differential/selective agar culture medium IVD

N/A - 00816576027125

Haemophilus ID Quadplate, for Haemophilus ID Quadplate consists of four separate formulations, which supply the requirements as follows: RTF Casman Medium, Modified (X- and V-factors) Tryptic Soy Agar (TSA) with Hemin (X-factor) Tryptic Soy Agar (TSA), modified with NAD (V-factor) Chocolate Agar (X- and V-factors) For the differentiation of Haemophilus spp.X and V Factors, 15x100mm quadplate, order by the package of 10
HARDY DIAGNOSTICS
J82
In Commercial Distribution

  • 00816576027118 ()
  • 00816576027125 ()
J82

  • Differential/selective agar culture medium IVD

N/A - 00816576027101

Middlebrook 7H11 / 7H11 Selective Agar, 15x100mm Biplate, 16ml/16ml. Hardy Diagnostics Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
J75
In Commercial Distribution

  • 00816576027095 ()
  • 00816576027101 ()
J75

  • Multiple formulation agar culture medium IVD

N/A - 00816576026999

MacConkey Agar / EMB Agar, Levine, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. 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
J58
In Commercial Distribution

  • 00816576026982 ()
  • 00816576026999 ()
J58

  • Differential/selective agar culture medium IVD

N/A - 00816576026968

G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other microorganisms found in the female genitourinary tract.
HARDY DIAGNOSTICS
G367
In Commercial Distribution

  • 00816576026951 ()
  • 00816576026968 ()
G367

  • Differential/selective agar culture medium IVD

N/A - 00816576026920

CIN Agar / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
J49
In Commercial Distribution

  • 00816576026913 ()
  • 00816576026920 ()
J49

  • Multiple formulation agar culture medium IVD

N/A - 00816576026906

Corn Meal with Tween® 80, 15x100mm Biplate, 13ml/13ml. Hardy Diagnostics Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.
HARDY DIAGNOSTICS
J48
Not in Commercial Distribution

  • 00816576026890 ()
  • 00816576026906 ()
J48

  • Differential/selective agar culture medium IVD

N/A - 00816576026821

Derm-Duet™, RSM™/DTM, 15x100mm Biplate, 15ml/15ml. Hardy Diagnostics’ Bacti-Lab Skin Culture Systems™ are diagnostic culture test kits for the detection of dermatophytic fungi. The culture media is ready-for-use and provides simplified culture procedures for the isolation, detection and speciation of dermatophytes (Microsporum, Epidermophyton, Trichophyton) commonly seen from hair, skin, and nail specimens in a human or veterinary clinical setting.
HARDY DIAGNOSTICS
J350
In Commercial Distribution

  • 00816576026814 ()
  • 00816576026821 ()
J350

  • Multiple formulation agar culture medium IVD

N/A - 00816576026685

Tryptic Soy Broth (TSB), 10ml, 16x125mm tube, optically clear, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6036
Not in Commercial Distribution

  • 00816576026678 ()
  • 00816576026685 ()
6036

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026661

Tryptic Soy Broth (TSB), 2ml, 16x100mm tube, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also Known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6034
Not in Commercial Distribution

  • 00816576026616 ()
  • 00816576026661 ()
6034

  • Basic/simple nutrient broth culture medium IVD
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