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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 - 00819398027083

Nitrate Reagent B, Naphthylamine, 15ml For use in determining the nitrate reduction reaction of bacteria, other than Mycobacterium species.
HARDY DIAGNOSTICS
Z72
In Commercial Distribution

  • 00819398027083 ()
Z72

  • Nitrate reduction microbial reagent IVD

N/A - 00819398027076

AFB Nitrate Reagent B, (naphthylethylenediamine, 0.1%), for AFB Nitrate Test for mycobacteria identification, 15ml, AFB nitrate developer reagent is to be used with Nitrate Substrate Broth (Cat. no. R97) and AFB Nitrate Reagent A (Cat. no Z124). Reagent B contains naphthylethylenediamine 2HCL.
HARDY DIAGNOSTICS
Z125
In Commercial Distribution

  • 00819398027076 ()
Z125

  • Multiple Mycobacterium species culture isolate identification IVD, reagent

N/A - 00819398027069

Modified Field's Stain Kit, for protozoa such as Acanthamoeba, two 15ml bottles per kit Staining solution for microscopic examination of Protozoa such as Acanthamoeba and Trichomonas spp. Contains: Reagent A (1) 00819398027045 Reagent B (1) 00819398027052
HARDY DIAGNOSTICS
Z15
Not in Commercial Distribution

  • 00819398027069 ()
Z15

  • Biological stain 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 - 00819398026963

McFarland Standard, Latex Equivalent # 2, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML2
In Commercial Distribution

  • 00819398026963 ()
ML2

  • McFarland standard IVD

N/A - 00819398026956

McFarland Standard, Latex Equivalent # 3, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML3
In Commercial Distribution

  • 00819398026956 ()
ML3

  • McFarland standard IVD

N/A - 00819398026949

McFarland Standard, Latex Equivalent # 4, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML4
In Commercial Distribution

  • 00819398026949 ()
ML4

  • McFarland standard IVD

N/A - 00819398026932

McFarland Standard, Latex Equivalent # 5, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML5
In Commercial Distribution

  • 00819398026932 ()
ML5

  • McFarland standard IVD

N/A - 00819398026925

McFarland Standard, Latex Equivalent # 6, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML6
In Commercial Distribution

  • 00819398026925 ()
ML6

  • McFarland standard IVD

N/A - 00819398026918

McFarland Standard, Latex Equivalent # 7, 8ml fill, 16x100mm tube The McFarland Latex Standards are prepared from suspensions of uniform latex particles with similar absorbance values as the original barium sulfate standards.
HARDY DIAGNOSTICS
ML7
In Commercial Distribution

  • 00819398026918 ()
ML7

  • McFarland standard IVD
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