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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 Class Implantable

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FLUID THIOGLYCOLATE BROTH W/ IND 100ML
EDGE BIOLOGICALS, INC.
B0318
Not in Commercial Distribution

  • B645B0318 ()


  • Differential/selective broth culture medium IVD
THIOGLYCOLLATE BROTH W/ IND 7ML
EDGE BIOLOGICALS, INC.
T0715
Not in Commercial Distribution

  • B64507151 ()
  • B6450715 ()


  • Differential/selective broth culture medium IVD
Strep B Carrot Broth Tiles 1000 tiles/bag 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
CBT1000
In Commercial Distribution

  • 00819398027649 ()
  • 00819398028134 ()
CBT1000

  • Differential/selective broth culture medium IVD
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
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
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
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
Thionin Acetate, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube, order by the package of 20 For the speciation of Brucella.
HARDY DIAGNOSTICS
Z036
Not in Commercial Distribution

  • 00819398026369 ()
  • 00819398026376 ()
Z036

  • Differential/selective broth culture medium IVD
Rapid DNase Broth, Tube Flat Bottom 13x100mm EP Glass, 0.5ml fill, order by the package of 20 Hardy Diagnostics Rapid DNase Broth is recommended for the detection of deoxyribonuclease (DNase) activity of gram-negative and gram-positive bacteria, particularly Staphylococcus aureus, Moraxella catarrhalis, and Serratia marcescens. Positives turn the broth a milky white.
HARDY DIAGNOSTICS
Z24
Not in Commercial Distribution

  • 00819398026345 ()
  • 00819398026352 ()
Z24

  • Differential/selective broth culture medium IVD
OF Fructose Medium, 3ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of carbohydrate oxidation or fermentation by bacteria.
HARDY DIAGNOSTICS
Y58
In Commercial Distribution

  • 00819398026031 ()
  • 00819398026048 ()
Y58

  • Differential/selective broth culture medium IVD
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