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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 - 00819398026123

ALP(Aerobic Low Peptone) Maltose, Modified, 3ml, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y66
Not in Commercial Distribution

  • 00819398026116 ()
  • 00819398026123 ()
Y66

  • Differential/selective agar culture medium IVD

N/A - 00819398026109

ALP(Aerobic Low Peptone) Dextrose, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y63
Not in Commercial Distribution

  • 00819398026093 ()
  • 00819398026109 ()
Y63

  • Differential/selective agar culture medium IVD

N/A - 00819398026086

ALP(Aerobic Low Peptone) Arabinose, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y62
In Commercial Distribution

  • 00819398026079 ()
  • 00819398026086 ()
Y62

  • Differential/selective agar culture medium IVD

N/A - 00819398026062

ALP(Aerobic Low Peptone) Acetamide, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y61
Not in Commercial Distribution

  • 00819398026055 ()
  • 00819398026062 ()
Y61

  • Differential/selective agar culture medium IVD

N/A - 00819398026048

OF Fructose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y58
In Commercial Distribution

  • 00819398026031 ()
  • 00819398026048 ()
Y58

  • Differential/selective broth culture medium IVD

N/A - 00819398026024

OF Dextrose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y57
In Commercial Distribution

  • 00819398026017 ()
  • 00819398026024 ()
Y57

  • Differential/selective broth culture medium IVD

N/A - 00819398026000

OF Xylose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria
HARDY DIAGNOSTICS
Y56
In Commercial Distribution

  • 00819398025997 ()
  • 00819398026000 ()
Y56

  • Differential/selective broth culture medium IVD

N/A - 00819398025980

OF Sucrose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y55
In Commercial Distribution

  • 00819398025973 ()
  • 00819398025980 ()
Y55

  • Differential/selective broth culture medium IVD

N/A - 00819398025966

OF Lactose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y54
In Commercial Distribution

  • 00819398025959 ()
  • 00819398025966 ()
Y54

  • Differential/selective broth culture medium IVD

N/A - 00819398025942

OF Mannitol Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y53
In Commercial Distribution

  • 00819398025935 ()
  • 00819398025942 ()
Y53

  • Differential/selective broth culture medium IVD

N/A - 00819398025928

OF Maltose Medium, 3ml fill, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y52
In Commercial Distribution

  • 00819398025911 ()
  • 00819398025928 ()
Y52

  • Differential/selective broth culture medium IVD

N/A - 00819398025904

OF Base Medium (control), 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Control tube for fermentation testing of bacteria.
HARDY DIAGNOSTICS
Y51
In Commercial Distribution

  • 00819398025898 ()
  • 00819398025904 ()
Y51

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398025881

Moeller's Ornithine Decarboxylase, 5ml, 16x125mm tube, broth, order by the package of 20 For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids.
HARDY DIAGNOSTICS
Y44
In Commercial Distribution

  • 00819398025874 ()
  • 00819398025881 ()
Y44

  • Differential/selective broth culture medium IVD

N/A - 00819398025867

Moeller's Lysine Decarboxylase, 5ml fill, 16x125mm tube, order by the package of 20 For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids.
HARDY DIAGNOSTICS
Y43
In Commercial Distribution

  • 00819398025850 ()
  • 00819398025867 ()
Y43

  • Differential/selective broth culture medium IVD

N/A - 00819398025843

Moeller's Arginine Decarboxylase, 5ml fill, 16x125mm tube, order by the package of 20 For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids.
HARDY DIAGNOSTICS
Y42
In Commercial Distribution

  • 00819398025836 ()
  • 00819398025843 ()
Y42

  • Differential/selective broth culture medium IVD

N/A - 00819398025829

Moeller's Decarboxylase Base (control), 5ml fill, 16x125mm tube, order by the package of 20 For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids. A control tube for use with Y42, Y43, and Y44.
HARDY DIAGNOSTICS
Y41
In Commercial Distribution

  • 00819398025812 ()
  • 00819398025829 ()
Y41

  • Differential/selective broth culture medium IVD

N/A - 00819398025805

Phenol red broth base, 9mL, 16x125mm tube, 20 tubes/box For use as a negative control for Phenol Red Broth testing
HARDY DIAGNOSTICS
Y323
Not in Commercial Distribution

  • 00819398025799 ()
  • 00819398025805 ()
Y323

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398025782

Phenol Red Broth with Glycerol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y322
In Commercial Distribution

  • 00819398025775 ()
  • 00819398025782 ()
Y322

  • Differential/selective broth culture medium IVD

N/A - 00819398025768

Phenol Red Broth with Glucoside, 10ml fill, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y321
In Commercial Distribution

  • 00819398025751 ()
  • 00819398025768 ()
Y321

  • Differential/selective broth culture medium IVD

N/A - 00819398025744

Phenol Red Broth with Mannose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y319
In Commercial Distribution

  • 00819398025737 ()
  • 00819398025744 ()
Y319

  • Differential/selective broth culture medium IVD

N/A - 00819398025720

Phenol Red Broth with Xylose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y318
In Commercial Distribution

  • 00819398025713 ()
  • 00819398025720 ()
Y318

  • Differential/selective broth culture medium IVD

N/A - 00819398025706

Phenol Red Broth with Trehalose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y317
In Commercial Distribution

  • 00819398025690 ()
  • 00819398025706 ()
Y317

  • Differential/selective broth culture medium IVD

N/A - 00819398025683

Phenol Red Broth with Sucrose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y316
In Commercial Distribution

  • 00819398025676 ()
  • 00819398025683 ()
Y316

  • Differential/selective broth culture medium IVD

N/A - 00819398025669

Phenol Red Broth with Sorbitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y315
In Commercial Distribution

  • 00819398025652 ()
  • 00819398025669 ()
Y315

  • Differential/selective broth culture medium IVD

N/A - 00819398025645

Phenol Red Broth with Salicin, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y314
In Commercial Distribution

  • 00819398025638 ()
  • 00819398025645 ()
Y314

  • Differential/selective broth culture medium IVD

N/A - 00819398025621

Phenol Red Broth with Rhamnose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y313
In Commercial Distribution

  • 00819398025614 ()
  • 00819398025621 ()
Y313

  • Differential/selective broth culture medium IVD

N/A - 00819398025607

Phenol Red Broth with Raffinose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y312
In Commercial Distribution

  • 00819398025591 ()
  • 00819398025607 ()
Y312

  • Differential/selective broth culture medium IVD

N/A - 00819398025584

Phenol Red Broth with Mannitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y311
In Commercial Distribution

  • 00819398025577 ()
  • 00819398025584 ()
Y311

  • Differential/selective broth culture medium IVD

N/A - 00819398025560

Phenol Red Broth with Maltose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y310
In Commercial Distribution

  • 00819398025553 ()
  • 00819398025560 ()
Y310

  • Differential/selective broth culture medium IVD

N/A - 00819398025546

Phenol Red Broth with Lactose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y309
In Commercial Distribution

  • 00819398025539 ()
  • 00819398025546 ()
Y309

  • Differential/selective broth culture medium IVD

N/A - 00819398025522

Phenol Red Broth with Inulin, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y308
Not in Commercial Distribution

  • 00819398025515 ()
  • 00819398025522 ()
Y308

  • Differential/selective broth culture medium IVD

N/A - 00819398025508

Phenol Red Broth with Inositol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y307
In Commercial Distribution

  • 00819398025492 ()
  • 00819398025508 ()
Y307

  • Differential/selective broth culture medium IVD

N/A - 00819398025485

Phenol Red Broth with Galactose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y306
In Commercial Distribution

  • 00819398025478 ()
  • 00819398025485 ()
Y306

  • Differential/selective broth culture medium IVD

N/A - 00819398025461

Phenol Red Broth with Dulcitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y305
In Commercial Distribution

  • 00819398025454 ()
  • 00819398025461 ()
Y305

  • Differential/selective broth culture medium IVD

N/A - 00819398025447

Phenol Red Broth with Dextrose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation.
HARDY DIAGNOSTICS
Y304
In Commercial Distribution

  • 00819398025430 ()
  • 00819398025447 ()
Y304

  • Differential/selective broth culture medium IVD

N/A - 00819398025423

Phenol Red Broth with Arabinose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y302
In Commercial Distribution

  • 00819398025416 ()
  • 00819398025423 ()
Y302

  • Differential/selective broth culture medium IVD

N/A - 00819398025409

Phenol Red Broth with Adonitol, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
Y301
In Commercial Distribution

  • 00819398025393 ()
  • 00819398025409 ()
Y301

  • Differential/selective broth culture medium IVD

N/A - 00819398025386

MGP Broth, 2.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the differentiation of clinically significant Enterococcus spp. by the fermentation of MGP (methyl-alpha-D-glucopyranoside).
HARDY DIAGNOSTICS
Y25
In Commercial Distribution

  • 00819398025379 ()
  • 00819398025386 ()
Y25

  • Differential/selective broth culture medium IVD

N/A - 00819398025362

CTA (Cystine Tryptic Agar) with Salicin, 3ml 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
Y24
In Commercial Distribution

  • 00819398025355 ()
  • 00819398025362 ()
Y24

  • Differential/selective agar culture medium IVD

N/A - 00819398025348

Motility Nitrate, 3ml, 13x100mm tube, order by the package of 20 For the detection of motility and nitrate reduction of non-fermentative bacilli.
HARDY DIAGNOSTICS
Y23
In Commercial Distribution

  • 00819398025331 ()
  • 00819398025348 ()
Y23

  • Differential/selective broth culture medium IVD

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
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