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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 Class Implantable

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N/A - 00819398028004

Middlebrook 7H11 Select Slant, 20x125 tube, 20 tubes/box (Mitchison formula with CAPT antibiotics) For selective isolation of Mycobacterium spp.
HARDY DIAGNOSTICS
C38
In Commercial Distribution

  • 00819398020305 ()
  • 00819398028004 ()
C38

  • Differential/selective agar culture medium IVD

N/A - 00819398027656

Strep B Carrot Broth Tiles 50 tiles/jar For the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tile must be added to broth (not included) upon inoculation.
HARDY DIAGNOSTICS
CBT50
Not in Commercial Distribution

  • 00819398027649 ()
  • 00819398027656 ()
CBT50

  • Differential/selective broth culture medium IVD

N/A - 00819398027014

Page's Saline, for free-living amoeba Acanthomeoba and Naegleria, 2ml fill, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For use with Non-Nutrient Agar (Cat. No. G225) for detecting the presence of free-living amebae cysts and trophozoites in tissue, soil, or water samples.
HARDY DIAGNOSTICS
R225
In Commercial Distribution

  • 00819398027007 ()
  • 00819398027014 ()
R225

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398026857

Rapid Anginosus ID Kit, to assist in the identification of Streptococcus anginosis (S. milleri), 10 tests per kit For the rapid identification of the Streptococcus anginosus group (formerly S. milleri) by the detection of arginine decarboxylase activity and production of acetoin. Results in as little as four hours. Easy color change readout, time saving kit format is cost effective. Each kit contains: 10 tubes of Rapid Arginine 10 tubes of Rapid VP
HARDY DIAGNOSTICS
Z14
In Commercial Distribution

  • 00819398026857 ()
  • 00819398027045 ()
Z14

  • Voges-Proskauer (VP) microbial reagent IVD
  • Multiple Vibrio species culture isolate identification IVD, kit

LanaGram™ - 00819398026772

LanaGram™, rapid color test for bacterial gram reaction, 15 tests per package For organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram stain reaction of gram-negative and gram-positive aerobic or facultatively anaerobic rods or coccobacilli. This test is not recommended for use with gram-positive cocci, microaerophilic or obligate anaerobic organisms.
HARDY DIAGNOSTICS
Z49
In Commercial Distribution

  • 00819398026765 ()
  • 00819398026772 ()
Z49

  • Gram stain IVD, reagent

ParaCon - 00819398026710

ParaCon™ Filter Funnel, 96 per box Funnel device that provides a standard and consistent mesh size and allows filtration of fecal material without clogging.
HARDY DIAGNOSTICS
PK96
In Commercial Distribution

  • 00819398026703 ()
  • 00819398026710 ()
PK96

  • Basic/simple nutrient agar culture medium IVD

N/A - 00819398026567

Rapid Urea Medium, useful for Helicobacter pylori, 2ml, 15x45mm tube, 10 per box Rapid Urea Medium for rapid detection of urease activity in Helicobacter pylori, Cryptococcus neoformans, or Proteus spp. Biopsy specimen from endoscopy can be submerged into the agar, positive reactions (pink-red color) may be noted within minutes.
HARDY DIAGNOSTICS
Z54
In Commercial Distribution

  • 00819398026550 ()
  • 00819398026567 ()
Z54

  • Differential/selective broth culture medium IVD

N/A - 00819398026543

RSU Broth (rapid sucrose urea), for Corynebacterium jeikeium, 0.5ml, 10 tubes per package RSU Broth, 0.5ml (Rapid Sucrose Urea) minitube (15x45mm) culture test for the presumptive identification of Corynebacterium jeikeium. Same day results, performs a sucrose fermentation and urease test, both of which are negative for C. jeikeium.
HARDY DIAGNOSTICS
Z53
Not in Commercial Distribution

  • 00819398026536 ()
  • 00819398026543 ()
Z53

  • Differential/selective broth culture medium IVD

N/A - 00819398026451

Rapid MGP Media, for Enterococcus, 1.0ml, 20 tests per package A five hour test for the acidification of MGP to aid in the differentiation of clinically significant Enterococcus faecalis and fecium. Used to rule out non-pathogenic E. casseliflavus and E. gallinarum.
HARDY DIAGNOSTICS
Z225
In Commercial Distribution

  • 00819398026444 ()
  • 00819398026451 ()
Z225

  • Differential/selective broth culture medium IVD

N/A - 00819398026437

Rapid Trehalose Broth, 0.35ml, for Candida glabrata, optically clear, shatter resistant, polycarbonate tube, 20 tests per package Carbon Assimilation Test. For the identification of yeasts, especially Candida (Torulopsis) glabrata.
HARDY DIAGNOSTICS
Z205
In Commercial Distribution

  • 00819398026420 ()
  • 00819398026437 ()
Z205

  • Trehalose utilization microbial reagent IVD
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