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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 - 00816576025350

Caffeic Acid Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Caffeic Acid Agar Slant is recommended for the selective isolation and differentiation of Cryptococcus neoformans and Cryptococcus gattii.
HARDY DIAGNOSTICS
G213
In Commercial Distribution

  • 00816576025343 ()
  • 00816576025350 ()
G213

  • Differential/selective agar culture medium IVD

N/A - 00816576025336

SP4 Agar with Glucose, 15x60mm Plate, 11ml. Hardy Diagnostics SP4 Media are recommended for the isolation, differentiation and maintenance of mycoplasma, including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
HARDY DIAGNOSTICS
G21
In Commercial Distribution

  • 00816576025329 ()
  • 00816576025336 ()
G21

  • Differential/selective agar culture medium IVD

N/A - 00816576025312

BCYE Agar with DGVP, 15x100mm Plate, 18ml. Hardy Diagnostics 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. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G209
In Commercial Distribution

  • 00816576025305 ()
  • 00816576025312 ()
G209

  • Differential/selective agar culture medium IVD

N/A - 00816576025299

TSA with 6% Yeast Extract, 15x100 monoplate, 10/pk (Tryptic Soy Agar with 6% Yeast Extract) For the cultivation of microorganisms
HARDY DIAGNOSTICS
G204
In Commercial Distribution

  • 00816576025282 ()
  • 00816576025299 ()
G204

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576025275

Pseudomonas Agar P, 15x100mm Plate, 18ml. Pseudomonas Agar P, also known as Tech Agar, is recommended for enhancement of pyocyanin production by Pseudomonas aeruginosa.
HARDY DIAGNOSTICS
G201
Not in Commercial Distribution

  • 00816576025268 ()
  • 00816576025275 ()
G201

  • Differential/selective agar culture medium IVD

N/A - 00816576025251

CIN Agar, 15x100mm Plate, 18ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources.
HARDY DIAGNOSTICS
G20
In Commercial Distribution

  • 00816576025244 ()
  • 00816576025251 ()
G20

  • Differential/selective agar culture medium IVD

N/A - 00816576025114

PLET Agar, 15x100mm Plate, 20ml. Hardy Diagnostics PLET Agar (Polymyxin-Lysozyme-EDTA-Thallous acetate) is used for the detection and isolation of Bacillus anthracis from environmental samples, animal products, carcasses, and clinical samples from non-sterile sites. PLET Agar can be useful as a component of a screening program for anthrax.
HARDY DIAGNOSTICS
G153
In Commercial Distribution

  • 00816576025107 ()
  • 00816576025114 ()
G153

  • Differential/selective agar culture medium IVD

N/A - 00816576025077

Pseudomonas Isolation Agar, 15x60mm Plate, 11ml. Hardy Diagnostics Pseudomonas Isolation Agar is recommended for the selective isolation and differentiation of Pseudomonas aeruginosa.
HARDY DIAGNOSTICS
G145
In Commercial Distribution

  • 00816576025060 ()
  • 00816576025077 ()
G145

  • Differential/selective agar culture medium IVD

N/A - 00816576024896

Bile Esculin Agar (BEA) with Azide, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin with Azide Media are recommended for the isolation and differentiation of group D streptococci from non-group D streptococci.
HARDY DIAGNOSTICS
G11
In Commercial Distribution

  • 00816576024889 ()
  • 00816576024896 ()
G11

  • Differential/selective agar culture medium IVD

N/A - 00816576024810

Burkholderia cepacia Selective Agar (BCSA), USP, 15x100mm Plate, 18ml. Hardy Diagnostics Burkholderia cepacia Selective Agar (BCSA), USP is recommended for the selective isolation and differentiation of Burkholderia cepacia from sputum samples from cystic fibrosis patients and other clinical specimens. In addition, the medium complies with the U.S. Pharmacopoeia <60> for the Microbial Examination of Non-sterile Products–Tests for Burkholderia cepacia complex.
HARDY DIAGNOSTICS
G09
In Commercial Distribution

  • 00816576024803 ()
  • 00816576024810 ()
G09

  • Differential/selective agar culture medium IVD

N/A - 00816576024797

BCYE Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics 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. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G08
In Commercial Distribution

  • 00816576024780 ()
  • 00816576024797 ()
G08

  • Differential/selective agar culture medium IVD

N/A - 00816576024759

Campy, Blood-Free Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Campy, Blood-Free Agar is a selective medium recommended for the isolation and cultivation of Campylobacter jejuni , C. coli, and C. laridis from feces.
HARDY DIAGNOSTICS
G06
In Commercial Distribution

  • 00816576024742 ()
  • 00816576024759 ()
G06

  • Differential/selective agar culture medium IVD

N/A - 00816576024735

BBE Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bacteroides Bile Esculin Agar (BBE) is recommended for use in the rapid isolation and presumptive identification of Bacteroides fragilis group.
HARDY DIAGNOSTICS
G05
In Commercial Distribution

  • 00816576024384 ()
  • 00816576024735 ()
G05

  • Differential/selective agar culture medium IVD

N/A - 00816576024728

PPLO Selective Agar, 15x60mm Plate, 11ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.
HARDY DIAGNOSTICS
G04
In Commercial Distribution

  • 00816576024711 ()
  • 00816576024728 ()
G04

  • Differential/selective agar culture medium IVD

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 - 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

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
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