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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 - 00816576024704

A8 Agar, 15x60mm Plate, 11ml. Hardy Diagnostics A8 Agar is used for isolation and differentiation of genital mycoplasmas, i.e. Ureaplasma urealyticum and Mycoplasma hominis.
HARDY DIAGNOSTICS
G02
In Commercial Distribution

  • 00816576024698 ()
  • 00816576024704 ()
G02

  • Differential/selective agar culture medium IVD

N/A - 00816576024681

YM-11 Agar, 15x100mm Plate, 18ml. Hardy Diagnostics YM-11 Agar is recommended for the isolation of yeast and molds.
HARDY DIAGNOSTICS
G01
In Commercial Distribution

  • 00816576024674 ()
  • 00816576024681 ()
G01

  • Differential/selective agar culture medium IVD

N/A - 00816576024643

BCYE Agar with GVPC, without Cysteine, 15x100mm plate, order by the package of 10 Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria
HARDY DIAGNOSTICS
W76
In Commercial Distribution

  • 00816576023448 ()
  • 00816576024643 ()
W76

  • Differential/selective agar culture medium IVD

N/A - 00816576024636

Selenite Cystine Broth, 20ml For the selective enrichment of Salmonella spp. Cystine enhances growth of Salmonella spp.
HARDY DIAGNOSTICS
K120
In Commercial Distribution

  • 00816576024582 ()
  • 00816576024636 ()
K120

  • Differential/selective broth culture medium IVD

N/A - 00816576024599

Cetrimide Selective Agar (CET) / MacConkey Agar (MAC) / Vogel and Johnson Agar (VJ), 15x100mm triplate, 7ml/section. Hardy Diagnostics Cetrimide Selective Agar is recommended for the selective isolation and identification of Pseudomonas aeruginosa. 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 Vogel and Johnson Agar is a selective medium used for the detection of coagulase-positive, mannitol-positive Staphylococcus aureus strains in clinical specimens and foods.
HARDY DIAGNOSTICS
J314
In Commercial Distribution

  • 00816576023363 ()
  • 00816576024599 ()
J314

  • Multiple formulation agar culture medium IVD

N/A - 00816576024568

Chocolate with Bacitracin, 15x100mm Plate, 18ml. Hardy Diagnostics Chocolate Agar with Bacitracin is recommended for use in the isolation and cultivation of Haemophilus species from respiratory specimens containing mixed flora.
HARDY DIAGNOSTICS
E11
In Commercial Distribution

  • 00816576024551 ()
  • 00816576024568 ()
E11

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024544

Anaerobic PEA, Monoplate. Hardy Diagnostics AnaeroGRO™ Anaerobic PEA Agar is recommended for use as an enriched and selective medium for the cultivation and selective isolation of gram-positive and negative obligate anaerobic bacteria. It is useful in isolating obligate anaerobes from mixed flora, by inhibiting gram-negative facultative anaerobes and the control of swarming organisms.
HARDY DIAGNOSTICS
AG901
Not in Commercial Distribution

  • 00816576024544 ()
AG901

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024520

LKV Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ LKV (Laked Blood with Kanamycin and Vancomycin) Agar is recommended for use in the selective isolation and partial identification of obligately anaerobic gram-negative bacilli, such as Prevotella spp. and Bacteroides spp.
HARDY DIAGNOSTICS
AG601
Not in Commercial Distribution

  • 00816576024520 ()
AG601

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024513

Cycloserine-Cefoxitin Fructose Agar, 15x100mm Plate, 18ml. Hardy Diagnostics AnaeroGRO™ Cycloserine-Cefoxitin Fructose Agar (CCFA) is an enriched selective and differential medium recommended for the isolation and cultivation of Clostridium difficile from fecal specimens. C. difficile is a recognized cause of intestinal infections and pseudomembranous colitis following antibiotic therapy.
HARDY DIAGNOSTICS
AG501
Not in Commercial Distribution

  • 00816576024513 ()
AG501

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024506

Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics AnaeroGRO™ Egg Yolk Agar, Modified is an enriched, non-selective, and differential medium recommended for use in the detection of lecithinase and lipase production and proteolytic activity of certain obligate anaerobes and in the presumptive identification of various Clostridium, Fusobacterium, and Prevotella spp.; it is also used in the Nagler Test for the presumptive identification of Clostridium perfringens.
HARDY DIAGNOSTICS
AG401
In Commercial Distribution

  • 00816576024506 ()
AG401

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024391

Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp.
HARDY DIAGNOSTICS
AG051
Not in Commercial Distribution

  • 00816576024391 ()
AG051

  • Differential/selective agar culture medium IVD

N/A - 00816576024353

PEA with 5% Sheep Blood, 15x100mm Plate, 18ml. Hardy Diagnostics PEA with 5% Sheep Blood is a selective medium recommended for the isolation of gram-positive microorganisms, particularly gram-positive cocci, from mixed specimens.
HARDY DIAGNOSTICS
A93
In Commercial Distribution

  • 00816576024346 ()
  • 00816576024353 ()
A93

  • Differential/selective agar culture medium IVD

N/A - 00816576024339

Anaerobic PEA, 15x100mm Plate, 18ml. Hardy Diagnostics Anaerobic PEA Agar is recommended for use as an enriched medium for the cultivation and selective isolation of gram-positive and negative obligate anaerobic bacteria.
HARDY DIAGNOSTICS
A90
In Commercial Distribution

  • 00816576024322 ()
  • 00816576024339 ()
A90

  • Differential/selective agar culture medium IVD

N/A - 00816576024278

Group A Beta Strep Agar, 15x100mm Plate, 17ml Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
A72
In Commercial Distribution

  • 00816576024261 ()
  • 00816576024278 ()
A72

  • Differential/selective agar culture medium IVD

N/A - 00816576024230

Selective Strep Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Selective Strep Agar is a selective medium recommended for use in the primary isolation of all Streptococcus species, including streptococcal groups A (S. pyogenes), B (S. agalactiae), C, D, F, G, and S. pneumoniae, especially from repiratory specimens.
HARDY DIAGNOSTICS
A70
In Commercial Distribution

  • 00816576024223 ()
  • 00816576024230 ()
A70

  • Differential/selective agar culture medium IVD

N/A - 00816576024193

Rose Agar, 15x100mm Plate, 17ml. 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
A66
In Commercial Distribution

  • 00816576024186 ()
  • 00816576024193 ()
A66

  • Differential/selective agar culture medium IVD

N/A - 00816576024179

Regan-Lowe Agar, 15x100mm Plate, 22ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A65
In Commercial Distribution

  • 00816576024162 ()
  • 00816576024179 ()
A65

  • Differential/selective agar culture medium IVD

N/A - 00816576024155

Regan-Lowe Agar without Cephalexin, 15x100mm Plate, 24ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A63
In Commercial Distribution

  • 00816576024148 ()
  • 00816576024155 ()
A63

  • Differential/selective agar culture medium IVD

N/A - 00816576024131

Neomycin Anaerobic Blood Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Neomycin Anaerobic Agar is recommended for use in the primary isolation of fastidious anaerobic microorganisms.
HARDY DIAGNOSTICS
A62
In Commercial Distribution

  • 00816576024124 ()
  • 00816576024131 ()
A62

  • Differential/selective agar culture medium IVD

N/A - 00816576024117

LKV Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
HARDY DIAGNOSTICS
A60
In Commercial Distribution

  • 00816576024100 ()
  • 00816576024117 ()
A60

  • Differential/selective agar culture medium IVD
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