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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 - 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
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