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 Class Implantable

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BHI with CIPRO 10µg/mL, 5mL, 15x103mm tube, 20 tubes/pack (Brain Heart Infusion Broth wtih ciprofloxacin, 10µg/mL) For use as a pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
HARDY DIAGNOSTICS
K255
In Commercial Distribution

  • 00819398021227 ()
  • 00819398021234 ()
K258

  • Differential/selective broth culture medium IVD
Acanthamoeba Broth, 15x103mm Tube, 5ml. Hardy Diagnostics Acanthamoeba Broth, also known as Peptone-Yeast Extract-Glucose (PYG) Medium, is recommended for the maintenance of Acanthamoeba stock cultures.
HARDY DIAGNOSTICS
K225
In Commercial Distribution

  • 00819398021081 ()
  • 00819398021098 ()
K225

  • Differential/selective broth culture medium IVD
MacConkey Broth, 10mL, 16x125mm tube, 20 tubes/box For the detection of gram-negative, lactose fermenting bacilli. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
K194
In Commercial Distribution

  • 00819398021005 ()
  • 00819398021012 ()
K194

  • Differential/selective broth culture medium IVD
Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x103mm Tube, 5ml. Hardy Diagnostics Tryptic Soy Broth (TSB) with 6.5% NaCl is a growth medium recommended for the differentiation of enterococci from the group D streptococci. This medium is also useful as an enrichment step for increasing sensitivity in the detection of MRSA in high risk patients.
HARDY DIAGNOSTICS
K126
In Commercial Distribution

  • 00819398020749 ()
  • 00819398020756 ()
K126

  • Differential/selective broth culture medium IVD
Bile Esculin Azide Broth, 15x103mm Tube, 5ml. 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
K11
In Commercial Distribution

  • 00819398020664 ()
  • 00819398020671 ()
K11

  • Differential/selective broth culture medium IVD
Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and selective medium for the isolation and cultivation of Trichomonas species from clinical specimens, especially T. vaginalis.
HARDY DIAGNOSTICS
K02
Not in Commercial Distribution

  • 00819398020602 ()
  • 00819398020619 ()
K02

  • Differential/selective broth culture medium IVD
GN Broth, 15x103mm Tube, 6ml. Hardy Diagnostics GN (Gram-Negative) Broth is recommended for the selective enrichment of Shigella and Salmonella spp. in clinical and non-clinical specimens.
HARDY DIAGNOSTICS
K01
In Commercial Distribution

  • 00819398020589 ()
  • 00819398020596 ()
K01

  • Differential/selective broth culture medium IVD
Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x45mm Tube without tube label, 1.5ml fill, order by the package of 100 For the differentiation of Enterococci from Group D Streptococci.
HARDY DIAGNOSTICS
D07
Not in Commercial Distribution

  • 00816576020003 ()
  • 00816576029075 ()
D07

  • Differential/selective broth culture medium IVD
Auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichment of Candida auris from patient and environmental samples
HARDY DIAGNOSTICS
R12
In Commercial Distribution

  • 00816576026876 ()
  • 00816576026883 ()
R12

  • Differential/selective broth culture medium IVD
SIM (Sulfide, Indole, Motility) Medium, 6ml, 16x125mm tube, order by the package of 10 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.
HARDY DIAGNOSTICS
7025
Not in Commercial Distribution

  • 00816576026692 ()
  • 00816576026708 ()
7025

  • Differential/selective broth culture medium IVD
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