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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 - 00819398025324

FLN (Florescence-Lactose-Dentrification) Agar Slant for NFB (Non-Fermentative Gram Negative Bacilli), 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli by fluorscein pigment production, lactose utilization, and nitrate reduction. See technical insert.
HARDY DIAGNOSTICS
Y22
Not in Commercial Distribution

  • 00819398025317 ()
  • 00819398025324 ()
Y22

  • Differential/selective agar culture medium IVD

N/A - 00819398025300

FID (Fluorescence-Indole-Dentrification) Agar Slant for NFB (Non-Fermentative Gram Negative Bacilli), 4.5ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli by fluorescein pigment production, nitrate reduction, and indole production.
HARDY DIAGNOSTICS
Y21
In Commercial Distribution

  • 00819398025294 ()
  • 00819398025300 ()
Y21

  • Differential/selective agar culture medium IVD

N/A - 00819398025287

Trehalose Fermentation Broth, 5ml, 13x100mm tube with durham tube, order by the package of 20 For the determination of fermentation reactions in yeasts. When incubated at 42 deg. C aids in the identification of Candida glabrata.
HARDY DIAGNOSTICS
Y205
In Commercial Distribution

  • 00819398025270 ()
  • 00819398025287 ()
Y205

  • Differential/selective broth culture medium IVD

N/A - 00819398025263

CTA (Cystine Tryptic Agar) with Trehalose, 3ml 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
Y20
In Commercial Distribution

  • 00819398025256 ()
  • 00819398025263 ()
Y20

  • Differential/selective agar culture medium IVD

N/A - 00819398025249

CTA (Cystine Tryptic Agar) with Xylose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics CTA Media are recommended for the determination of carbohydrate fermentation by fastidious organisms such as Neisseria spp. They are also used for the detection of bacterial motility and serve as a culture media for microorganism maintenance.
HARDY DIAGNOSTICS
Y19
In Commercial Distribution

  • 00819398025232 ()
  • 00819398025249 ()
Y19

  • Differential/selective agar culture medium IVD

N/A - 00819398025225

CTA (Cystine Tryptic Agar) with Mannose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y18
Not in Commercial Distribution

  • 00819398025218 ()
  • 00819398025225 ()
Y18

  • Differential/selective agar culture medium IVD

N/A - 00819398025201

CTA (Cystine Tryptic Agar) with Sorbitol, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y17
In Commercial Distribution

  • 00819398025195 ()
  • 00819398025201 ()
Y17

  • Differential/selective agar culture medium IVD

N/A - 00819398025188

CTA (Cystine Tryptic Agar) with Sucrose, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y16
In Commercial Distribution

  • 00819398025171 ()
  • 00819398025188 ()
Y16

  • Differential/selective agar culture medium IVD

N/A - 00819398025164

CTA (Cystine Tryptic Agar) with Mannitol, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp. p.
HARDY DIAGNOSTICS
Y15
In Commercial Distribution

  • 00819398025157 ()
  • 00819398025164 ()
Y15

  • Differential/selective agar culture medium IVD

N/A - 00819398025140

Urea R Broth, 1ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the rapid detection of urease activity by microorganisms.
HARDY DIAGNOSTICS
Y141
In Commercial Distribution

  • 00819398025133 ()
  • 00819398025140 ()
Y141

  • Differential/selective broth culture medium IVD

N/A - 00819398025126

CTA (Cystine Tryptic Agar) with Maltose, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y14
In Commercial Distribution

  • 00819398025119 ()
  • 00819398025126 ()
Y14

  • Differential/selective agar culture medium IVD

N/A - 00819398025102

Pyruvate Broth, 5ml, 15x103mm , optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the determination of pyruvate utilization in bacteria.
HARDY DIAGNOSTICS
Y130
In Commercial Distribution

  • 00819398025096 ()
  • 00819398025102 ()
Y130

  • Differential/selective broth culture medium IVD

N/A - 00819398025089

CTA (Cystine Tryptic Agar) with Lactose, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y13
In Commercial Distribution

  • 00819398025072 ()
  • 00819398025089 ()
Y13

  • Differential/selective agar culture medium IVD

N/A - 00819398025065

Carbon Utilization Citrate Slant, 8ml, 20x125mm tube, order by the package of 20 Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.
HARDY DIAGNOSTICS
Y128
Not in Commercial Distribution

  • 00819398025058 ()
  • 00819398025065 ()
Y128

  • Differential/selective agar culture medium IVD

N/A - 00819398025041

Carbon Utilization Mannitol Slant, 8ml, 20x125mm tube, order by the package of 20 Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.
HARDY DIAGNOSTICS
Y127
Not in Commercial Distribution

  • 00819398025034 ()
  • 00819398025041 ()
Y127

  • Differential/selective agar culture medium IVD

N/A - 00819398025027

Carbon Utilization with Inositol Slant, 8ml, 20x125mm tube, order by the package of 20 Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.
HARDY DIAGNOSTICS
Y126
Not in Commercial Distribution

  • 00819398025010 ()
  • 00819398025027 ()
Y126

  • Differential/selective agar culture medium IVD

N/A - 00819398025003

Carbon Utilization Base Slant, (control) 8ml, 20x125mm tube, order by the package of 20 Hardy Diagnostics Carbon Utilization Media with added carbon sources are recommended for use in the cultivation and differentiation of a wide variety of rapidly growing mycobacteria.
HARDY DIAGNOSTICS
Y125
Not in Commercial Distribution

  • 00819398024990 ()
  • 00819398025003 ()
Y125

  • Differential/selective agar culture medium IVD

N/A - 00819398024983

CTA (Cystine Tryptic Agar) with Dextrose, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Cystine Tryptic Agar with Carbohydrates) For fermentation testing of fastidious bacteria, such as Neisseria spp.
HARDY DIAGNOSTICS
Y12
In Commercial Distribution

  • 00819398024976 ()
  • 00819398024983 ()
Y12

  • Differential/selective agar culture medium IVD

N/A - 00819398024969

Purple Broth with Mannose, 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
Y119
Not in Commercial Distribution

  • 00819398024952 ()
  • 00819398024969 ()
Y119

  • Differential/selective broth culture medium IVD

N/A - 00819398024945

Purple Broth with Xylose, 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
Y117
Not in Commercial Distribution

  • 00819398024938 ()
  • 00819398024945 ()
Y117

  • Differential/selective broth culture medium IVD
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