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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 - 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 - 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
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