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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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AnaeroGRO - 00819398026338

Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens.
HARDY DIAGNOSTICS
AG25H
In Commercial Distribution

  • 00819398026321 ()
  • 00819398026338 ()
AG25H

  • Anaerobic transport medium IVD

N/A - 00819398023818

Viral Transport Medium VTM, 3ml fill (swabs sold separately), order by the package of 20 Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
HARDY DIAGNOSTICS
R99
In Commercial Distribution

  • 00819398023801 ()
  • 00819398023818 ()
R99

  • Microbiological transport medium IVD

N/A - 00819398023610

GN Broth, 12x80mm tube, 4ml fill, order by the package of 100 For the selective enrichment of Salmonella and Shigella spp. in stool specimens.
HARDY DIAGNOSTICS
R76BX
In Commercial Distribution

  • 00819398023603 ()
  • 00819398023610 ()
R76BX

  • Differential/selective broth culture medium IVD

N/A - 00819398022859

SIM (Sulfide, Indole, Motility) Medium, 8ml, 16x100mm tube, order by the package of 20 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.
HARDY DIAGNOSTICS
Q30
In Commercial Distribution

  • 00819398022842 ()
  • 00819398022859 ()
Q30

  • Differential/selective broth culture medium IVD

N/A - 00819398022439

LIM Broth, 5mL, 16x100mm skirted PP tube, 100 tubes/box For the selective enrichment of group B streptococci (Streptococcus agalactiae). Especially for anovaginal specimens from pregnant women. Compatible with automated inoculation systems.
HARDY DIAGNOSTICS
L59
Not in Commercial Distribution

  • 00819398022422 ()
  • 00819398022439 ()
L59

  • Differential/selective broth culture medium IVD

N/A - 00819398022415

LIM Broth, for Group B Strep, 5ml fill, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 LIM Broth is recommended for the selective enrichment of group B streptococci (Streptococcus agalactiae) from anovaginal specimens from pregnant women
HARDY DIAGNOSTICS
L57
In Commercial Distribution

  • 00819398022408 ()
  • 00819398022415 ()
L57

  • Differential/selective broth culture medium IVD

N/A - 00819398021234

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

N/A - 00819398021098

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

N/A - 00819398021012

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

N/A - 00819398020756

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
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