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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 - 00816576026920

CIN Agar / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
J49
In Commercial Distribution

  • 00816576026913 ()
  • 00816576026920 ()
J49

  • Multiple formulation agar culture medium IVD

N/A - 00816576026906

Corn Meal with Tween® 80, 15x100mm Biplate, 13ml/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
J48
Not in Commercial Distribution

  • 00816576026890 ()
  • 00816576026906 ()
J48

  • Differential/selective agar culture medium IVD

N/A - 00816576026821

Derm-Duet™, RSM™/DTM, 15x100mm Biplate, 15ml/15ml. Hardy Diagnostics’ Bacti-Lab Skin Culture Systems™ are diagnostic culture test kits for the detection of dermatophytic fungi. The culture media is ready-for-use and provides simplified culture procedures for the isolation, detection and speciation of dermatophytes (Microsporum, Epidermophyton, Trichophyton) commonly seen from hair, skin, and nail specimens in a human or veterinary clinical setting.
HARDY DIAGNOSTICS
J350
In Commercial Distribution

  • 00816576026814 ()
  • 00816576026821 ()
J350

  • Multiple formulation agar culture medium IVD

N/A - 00816576026685

Tryptic Soy Broth (TSB), 10ml, 16x125mm tube, optically clear, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6036
Not in Commercial Distribution

  • 00816576026678 ()
  • 00816576026685 ()
6036

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026661

Tryptic Soy Broth (TSB), 2ml, 16x100mm tube, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also Known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6034
Not in Commercial Distribution

  • 00816576026616 ()
  • 00816576026661 ()
6034

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026630

Bile Esculin Agar / Sodium Chloride (NaCl) 6.5% without Indicator, 15x100mm Biplate, 10ml/10ml. 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 NaCl 6.5% Media are recommended for use in salt tolerance testing to differentiate Enterococcus from non-enterococcal group D streptococci.
HARDY DIAGNOSTICS
J165
Not in Commercial Distribution

  • 00816576026623 ()
  • 00816576026630 ()
J165

  • Multiple formulation agar culture medium IVD

N/A - 00816576026609

Thioglycollate w/o Indicator, 10mL,16x125mm tube,10 tubes/box. For the cultivation of microorganisms. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
6020
Not in Commercial Distribution

  • 00816576026463 ()
  • 00816576026609 ()
6020

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026593

Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective and differential medium used for the isolation and differentiation of gram-negative enteric pathogens. Hardy Diagnostics SS Agar is recommended for use as a selective and differential medium for the isolation of Salmonella and some Shigella species from clinical and non-clinical specimens.
HARDY DIAGNOSTICS
J139
Not in Commercial Distribution

  • 00816576026586 ()
  • 00816576026593 ()
J139

  • Multiple formulation agar culture medium IVD

N/A - 00816576026579

Arcano Select / Group A Beta Strep Biplate, 15x100mm Plate, 10ml/10ml. Hardy Diagnostics Arcanobacterium Selective Agar is recommended for use as a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J134
Not in Commercial Distribution

  • 00816576026562 ()
  • 00816576026579 ()
J134

  • Multiple formulation agar culture medium IVD

N/A - 00816576026500

MacConkey/MacConkey Biplate 15x100 biplate, 10/pk (MacConkey Agar) For the isolation and differentiation of gram-negative bacteria. Some ingredients are very light sensitive. Store and incubate media in the dark
HARDY DIAGNOSTICS
J118
In Commercial Distribution

  • 00816576026494 ()
  • 00816576026500 ()
J118

  • Differential/selective agar culture medium IVD
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