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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BD BBL™ Columbia CNA Agar with 5% Sheep Blood
BECTON, DICKINSON AND COMPANY
221353
In Commercial Distribution

  • 10382902213533 ()
  • 00382902213536 ()
  • 30382902213537 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221353

  • Differential/selective agar culture medium IVD
BD BBL™ Columbia CNA Agar with 5% Sheep Blood
BECTON, DICKINSON AND COMPANY
221352
Not in Commercial Distribution

  • 10382902213526 ()
  • 00382902213529 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221352

  • Differential/selective agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and MacConkey II Agar I Plate™
BECTON, DICKINSON AND COMPANY
221291
In Commercial Distribution

  • 10382902212918 ()
  • 00382902212911 ()
  • 30382902212912 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221291

  • Multiple formulation agar culture medium IVD
Plate Tsa II SB//Mac II 20 Ea
BECTON, DICKINSON AND COMPANY
221290
Not in Commercial Distribution

  • 10382902212901 ()
  • 30382902212905 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221290

  • Multiple formulation agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB Agar
BECTON, DICKINSON AND COMPANY
221289
In Commercial Distribution

  • 10382902212895 ()
  • 00382902212898 ()
  • 30382902212899 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221289

  • Multiple formulation agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and Levine EMB Agar I Plate™
BECTON, DICKINSON AND COMPANY
221286
Not in Commercial Distribution

  • 10382902212864 ()
  • 00382902212867 ()
  • 30382902212868 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221286

  • Multiple formulation agar culture medium IVD
BD BBL™ XLD Agar, Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221284
In Commercial Distribution

  • 10382902212840 ()
  • 00382902212843 ()
  • 60382902212845 ()
  • 30382902212844 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221284

  • Differential/selective agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar)
BECTON, DICKINSON AND COMPANY
221283
In Commercial Distribution

  • 10382902212833 ()
  • 00382902212836 ()
  • 30382902212837 ()
  • 60382902212838 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221283

  • Basic/simple nutrient agar culture medium IVD
BD BBL™ Sabouraud Dextrose Agar (Deep Fill), Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221278
In Commercial Distribution

  • 30382902212783 ()
  • 10382902212789 ()
  • 00382902212782 ()

  • Outer Diameter: 100 Millimeter
221278

  • Differential/selective agar culture medium IVD
BD BBL™ Phenylethyl Alcohol Agar with 5% Sheep Blood, Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221277
In Commercial Distribution

  • 10382902212772 ()
  • 00382902212775 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221277

  • Differential/selective agar culture medium IVD
BD BBL™ Mannitol Salt Agar
BECTON, DICKINSON AND COMPANY
221271
In Commercial Distribution

  • 10382902212710 ()
  • 00382902212713 ()
  • 30382902212714 ()
  • 60382902212715 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221271

  • Differential/selective agar culture medium IVD
BD BBL™ MacConkey II Agar, Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221270
In Commercial Distribution

  • 10382902212703 ()
  • 00382902212706 ()
  • 60382902212708 ()
  • 30382902212707 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221270

  • Differential/selective agar culture medium IVD
BD BBL™ Levine EMB Agar
BECTON, DICKINSON AND COMPANY
221268
Not in Commercial Distribution

  • 10382902212680 ()
  • 00382902212683 ()
  • 30382902212684 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221268

  • Differential/selective agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II), Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221261
In Commercial Distribution

  • 30382902212615 ()
  • 10382902212611 ()
  • 60382902212616 ()
  • 00382902212614 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221261

  • Enriched agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood
BECTON, DICKINSON AND COMPANY
221239
Not in Commercial Distribution

  • 10382902212390 ()
  • 00382902212393 ()
  • 60382902212395 ()
  • 30382902212394 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221239

  • Enriched agar culture medium IVD
BD BBL™ XLD Agar
BECTON, DICKINSON AND COMPANY
221192
Not in Commercial Distribution

  • 10382902211928 ()
  • 00382902211921 ()
  • 30382902211922 ()
  • 60382902211923 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221192

  • Differential/selective agar culture medium IVD
BD BBL™ Trypticase™ Soy Agar Soybean-Casein Digest Agar
BECTON, DICKINSON AND COMPANY
221185
Not in Commercial Distribution

  • 10382902211850 ()
  • 00382902211853 ()
  • 30382902211854 ()
  • 60382902211855 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221185

  • Basic/simple nutrient agar culture medium IVD
BD BBL™ Salmonella Shigella Agar
BECTON, DICKINSON AND COMPANY
221181
Not in Commercial Distribution

  • 10382902211812 ()
  • 00382902211815 ()
  • 30382902211816 ()
  • 60382902211817 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221181

  • Differential/selective agar culture medium IVD
BD BBL™ Sabouraud Dextrose Agar
BECTON, DICKINSON AND COMPANY
221180
Not in Commercial Distribution

  • 10382902211805 ()
  • 00382902211808 ()
  • 30382902211809 ()
  • 60382902211800 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221180

  • Basic/simple nutrient agar culture medium IVD
BD BBL™ Phenylethyl Alcohol Agar with 5% Sheep Blood
BECTON, DICKINSON AND COMPANY
221179
Not in Commercial Distribution

  • 10382902211799 ()
  • 00382902211792 ()
  • 60382902211794 ()
  • 30382902211793 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221179

  • Differential/selective agar culture medium IVD
Plate Mannitol Salt Agar 20 Ea
BECTON, DICKINSON AND COMPANY
221173
Not in Commercial Distribution

  • 10382902211737 ()
  • 00382902211730 ()
  • 30382902211731 ()
  • 60382902211732 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221173

  • Differential/selective agar culture medium IVD
BD BBL™ MacConkey II Agar
BECTON, DICKINSON AND COMPANY
221172
Not in Commercial Distribution

  • 10382902211720 ()
  • 00382902211723 ()
  • 30382902211724 ()
  • 60382902211725 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
221172

  • Differential/selective agar culture medium IVD
BD BBL™ Levine EMB Agar
BECTON, DICKINSON AND COMPANY
221170
Not in Commercial Distribution

  • 10382902211706 ()
  • 00382902211709 ()
  • 30382902211700 ()
  • 60382902211701 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
221170

  • Differential/selective agar culture medium IVD
BBL™ CHROMagar™ Orientation
BECTON, DICKINSON AND COMPANY
215081
In Commercial Distribution

  • 10382902150814 ()
  • 00382902150817 ()
  • 30382902150818 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
215081

  • Differential/selective agar culture medium IVD
BD BBL™ CHROMAgar™ 0157
BECTON, DICKINSON AND COMPANY
214984
Not in Commercial Distribution

  • 10382902149849 ()
  • 00382902149842 ()
  • 30382902149843 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
214984

  • Differential/selective agar culture medium IVD
BD BBL™ CHROMagar™ Staph aureus, Pkg. of 20 plates
BECTON, DICKINSON AND COMPANY
214982
In Commercial Distribution

  • 30382902149829 ()
  • 10382902149825 ()
  • 00382902149828 ()
214982

  • Differential/selective agar culture medium IVD
Nocardia Hydrolysis Kit for Actinomycetes, 18ml, (Total of 20 tubes) 20x125mm tubes of 4 different media types (5 each of Casein, Xanthine, Hypoxanthine, and Tyrosine Agars, in 20x125mm tubes, deep) (Nocardia Hydrolysis Kit) For use in determining the hydrolysis reaction on casein, xanthine, hypoxanthine, and tyrosine by Nocardia, Actinomycetales, Actinomadura, and Streptomyces spp. Box contains 5 tubes of each media. 20 tubes total. Contains: Casein Agar, Deep 18ml (5) 00819398022941 Xanthine Agar, Deep 18ml (5) 00819398028462 Hypoxathine Agar, Deep 18ml (5) 00819398028479 Tyrosine Agar, Deep 18ml (5) 00819398028486
HARDY DIAGNOSTICS
Z604
In Commercial Distribution

  • 00819398028493 ()
Z604

  • Differential/selective agar culture medium IVD
Basic Fuchsin, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube, For the speciation of Brucella.
HARDY DIAGNOSTICS
Z006
Not in Commercial Distribution

  • 00819398028448 ()
  • 00819398028455 ()
Z006

  • Differential/selective agar culture medium IVD
MycoVue™ Slide Culture System, Potato Flake Agar, ready-to-use, includes cover slip and humidifier, 5 trays per box A ready-to-use slide culture system for the cultivation of fungi. Simplify your fungal slide cultures while saving money, reducing frustration, and eliminating preparation time. Desiccation is prevented with a built in humidity chamber and the culture can be incubated for long periods of time. Device fits conveniently on the microscope stage for easy observation without disturbing the fungal structures.
HARDY DIAGNOSTICS
MV1
In Commercial Distribution

  • 00819398028257 ()
  • 00819398028264 ()
MV1

  • Basic/simple nutrient agar culture medium IVD
CAN Agar, 15x100 monoplate, 10/pk For the cultivation of yeast
HARDY DIAGNOSTICS
G238
In Commercial Distribution

  • 00819398028219 ()
  • 00819398028226 ()
G238

  • Differential/selective agar culture medium IVD
Strep B Carrot Broth Tiles 1000 tiles/bag For the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tile must be added to broth (not included) upon inoculation.
HARDY DIAGNOSTICS
CBT1000
In Commercial Distribution

  • 00819398027649 ()
  • 00819398028134 ()
CBT1000

  • Differential/selective broth culture medium IVD
Middlebrook 7H11 Select Slant, 20x125 tube, 20 tubes/box (Mitchison formula with CAPT antibiotics) For selective isolation of Mycobacterium spp.
HARDY DIAGNOSTICS
C38
In Commercial Distribution

  • 00819398020305 ()
  • 00819398028004 ()
C38

  • Differential/selective agar culture medium IVD
Strep B Carrot Broth Tiles 50 tiles/jar For the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tile must be added to broth (not included) upon inoculation.
HARDY DIAGNOSTICS
CBT50
Not in Commercial Distribution

  • 00819398027649 ()
  • 00819398027656 ()
CBT50

  • Differential/selective broth culture medium IVD
Page's Saline, for free-living amoeba Acanthomeoba and Naegleria, 2ml fill, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For use with Non-Nutrient Agar (Cat. No. G225) for detecting the presence of free-living amebae cysts and trophozoites in tissue, soil, or water samples.
HARDY DIAGNOSTICS
R225
In Commercial Distribution

  • 00819398027007 ()
  • 00819398027014 ()
R225

  • Basic/simple nutrient broth culture medium IVD
Rapid Anginosus ID Kit, to assist in the identification of Streptococcus anginosis (S. milleri), 10 tests per kit For the rapid identification of the Streptococcus anginosus group (formerly S. milleri) by the detection of arginine decarboxylase activity and production of acetoin. Results in as little as four hours. Easy color change readout, time saving kit format is cost effective. Each kit contains: 10 tubes of Rapid Arginine 10 tubes of Rapid VP
HARDY DIAGNOSTICS
Z14
In Commercial Distribution

  • 00819398026857 ()
  • 00819398027045 ()
Z14

  • Voges-Proskauer (VP) microbial reagent IVD
  • Multiple Vibrio species culture isolate identification IVD, kit
LanaGram™, rapid color test for bacterial gram reaction, 15 tests per package For organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram stain reaction of gram-negative and gram-positive aerobic or facultatively anaerobic rods or coccobacilli. This test is not recommended for use with gram-positive cocci, microaerophilic or obligate anaerobic organisms.
HARDY DIAGNOSTICS
Z49
In Commercial Distribution

  • 00819398026765 ()
  • 00819398026772 ()
Z49

  • Gram stain IVD, reagent
ParaCon™ Filter Funnel, 96 per box Funnel device that provides a standard and consistent mesh size and allows filtration of fecal material without clogging.
HARDY DIAGNOSTICS
PK96
In Commercial Distribution

  • 00819398026703 ()
  • 00819398026710 ()
PK96

  • Basic/simple nutrient agar culture medium IVD
Rapid Urea Medium, useful for Helicobacter pylori, 2ml, 15x45mm tube, 10 per box Rapid Urea Medium for rapid detection of urease activity in Helicobacter pylori, Cryptococcus neoformans, or Proteus spp. Biopsy specimen from endoscopy can be submerged into the agar, positive reactions (pink-red color) may be noted within minutes.
HARDY DIAGNOSTICS
Z54
In Commercial Distribution

  • 00819398026550 ()
  • 00819398026567 ()
Z54

  • Differential/selective broth culture medium IVD
RSU Broth (rapid sucrose urea), for Corynebacterium jeikeium, 0.5ml, 10 tubes per package RSU Broth, 0.5ml (Rapid Sucrose Urea) minitube (15x45mm) culture test for the presumptive identification of Corynebacterium jeikeium. Same day results, performs a sucrose fermentation and urease test, both of which are negative for C. jeikeium.
HARDY DIAGNOSTICS
Z53
Not in Commercial Distribution

  • 00819398026536 ()
  • 00819398026543 ()
Z53

  • Differential/selective broth culture medium IVD
Rapid MGP Media, for Enterococcus, 1.0ml, 20 tests per package A five hour test for the acidification of MGP to aid in the differentiation of clinically significant Enterococcus faecalis and fecium. Used to rule out non-pathogenic E. casseliflavus and E. gallinarum.
HARDY DIAGNOSTICS
Z225
In Commercial Distribution

  • 00819398026444 ()
  • 00819398026451 ()
Z225

  • Differential/selective broth culture medium IVD
Rapid Trehalose Broth, 0.35ml, for Candida glabrata, optically clear, shatter resistant, polycarbonate tube, 20 tests per package Carbon Assimilation Test. For the identification of yeasts, especially Candida (Torulopsis) glabrata.
HARDY DIAGNOSTICS
Z205
In Commercial Distribution

  • 00819398026420 ()
  • 00819398026437 ()
Z205

  • Trehalose utilization microbial reagent IVD
Thionin Acetate, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube, order by the package of 20 For the speciation of Brucella.
HARDY DIAGNOSTICS
Z036
Not in Commercial Distribution

  • 00819398026369 ()
  • 00819398026376 ()
Z036

  • Differential/selective broth culture medium IVD
Rapid DNase Broth, Tube Flat Bottom 13x100mm EP Glass, 0.5ml fill, order by the package of 20 Hardy Diagnostics Rapid DNase Broth is recommended for the detection of deoxyribonuclease (DNase) activity of gram-negative and gram-positive bacteria, particularly Staphylococcus aureus, Moraxella catarrhalis, and Serratia marcescens. Positives turn the broth a milky white.
HARDY DIAGNOSTICS
Z24
Not in Commercial Distribution

  • 00819398026345 ()
  • 00819398026352 ()
Z24

  • Differential/selective broth culture medium IVD
ParaCon™ Filter Funnel, 1000 per case Funnel device that provides a standard and consistent mesh size and allows filtration of fecal material without clogging.
HARDY DIAGNOSTICS
PK1000
In Commercial Distribution

  • 00819398026703 ()
  • 00819398026314 ()
PK1000

  • Basic/simple nutrient agar culture medium IVD
Potato Flake Agar, Slant, 10ml fill, 20x125mm tube, order by the package 20 Hardy Diagnostics Potato Flake Media is used in the cultivation, isolation, and induction of sporulation of fungi from clinical specimens.
HARDY DIAGNOSTICS
L48
In Commercial Distribution

  • 00819398026260 ()
  • 00819398026277 ()
L48

  • Basic/simple nutrient agar culture medium IVD
ALP(Aerobic Low Peptone) Xylose, Modified, 3ml fill, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y71
In Commercial Distribution

  • 00819398026215 ()
  • 00819398026222 ()
Y71

  • Differential/selective agar culture medium IVD
ALP(Aerobic Low Peptone) Urea, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y70
In Commercial Distribution

  • 00819398026192 ()
  • 00819398026208 ()
Y70

  • Differential/selective agar culture medium IVD
ALP(Aerobic Low Peptone) Sucrose, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y69
Not in Commercial Distribution

  • 00819398026178 ()
  • 00819398026185 ()
Y69

  • Differential/selective agar culture medium IVD
ALP(Aerobic Low Peptone) Lactose, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y68
Not in Commercial Distribution

  • 00819398026154 ()
  • 00819398026161 ()
Y68

  • Differential/selective agar culture medium IVD
ALP(Aerobic Low Peptone) Mannitol, Modified, 3ml slant, 13x100mm tube, order by the package of 10 For the identification of non-fermentative bacilli
HARDY DIAGNOSTICS
Y67
Not in Commercial Distribution

  • 00819398026130 ()
  • 00819398026147 ()
Y67

  • Differential/selective agar culture medium IVD
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