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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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Czapek Yeast Agar, deep fill, 15x100mm, order by the package of 10 For the isolation and cultivation of yeasts.
HARDY DIAGNOSTICS
W117
Not in Commercial Distribution

  • 00816576027293 ()
  • 00816576027309 ()
W117

  • Differential/selective agar culture medium IVD
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
Middlebrook 7H11 Thin Pour, for microscopic examination, 10x100mm Space Saver plate, order by the package of 15 For the isolation and detection of mycobacteria using the microcolony method. Thin pour plate for microscopic examination. Use with MycoSeals (cat. no. SS9225)
HARDY DIAGNOSTICS
SP57
In Commercial Distribution

  • 00816576027255 ()
  • 00816576027262 ()
SP57

  • Enriched agar culture medium IVD
Blood Agar 5% / Blood Agar 5%, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
J93
In Commercial Distribution

  • 00816576027231 ()
  • 00816576027248 ()
J93

  • Enriched agar culture medium IVD
Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J92
Not in Commercial Distribution

  • 00816576027217 ()
  • 00816576027224 ()
J92

  • Multiple formulation agar culture medium IVD
Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pk For the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576027170 ()
  • 00816576027187 ()
J87

  • Multiple formulation agar culture medium IVD
Sab-Duet, 15x100 biplate, 10/pk (Section I: Dermatophyte Test Medium (DTM); Section II: Mycobiotic Agar) For the selective isolation of pathogenic fungi especially from hair, skin, and nail specimens. Some ingredients are very light sensitive. Store and incubate media in the dark.
HARDY DIAGNOSTICS
J850
In Commercial Distribution

  • 00816576027156 ()
  • 00816576027163 ()
J850

  • Multiple formulation agar culture medium IVD
Rose / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. 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 Rose Agar is recommended for use as a selective growth medium for the cultivation and isolation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
J85
In Commercial Distribution

  • 00816576027132 ()
  • 00816576027149 ()
J85

  • Multiple formulation agar culture medium IVD
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
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
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