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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 - 00816576024933

Bile Esculin Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin Agar (BEA) is recommended for use as a differential medium in the isolation and presumptive identification of enterococci/group D streptococci.
HARDY DIAGNOSTICS
G12
In Commercial Distribution

  • 00816576024926 ()
  • 00816576024933 ()
G12

  • Differential/selective agar culture medium IVD

N/A - 00816576024919

CGB Agar, 15x100mm Plate, 20ml. Hardy Diagnostics CGB Agar is recommended for the differentiation of Cryptococcus neoformans var. neoformans and Cryptococcus gattii (formerly C. neoformans var. gattii).
HARDY DIAGNOSTICS
G113
In Commercial Distribution

  • 00816576024902 ()
  • 00816576024919 ()
G113

  • 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 - 00816576024858

PPLO Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.
HARDY DIAGNOSTICS
G105
In Commercial Distribution

  • 00816576024841 ()
  • 00816576024858 ()
G105

  • Differential/selective agar culture medium IVD

N/A - 00816576024834

Corn Meal with Tween® 80, 15x60mm Plate, 13ml. Hardy Diagnostics Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.
HARDY DIAGNOSTICS
G101
Not in Commercial Distribution

  • 00816576024827 ()
  • 00816576024834 ()
G101

  • 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
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