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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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Potassium Hydroxide, 20% KOH, for skin fungal preps, 15ml dropper vial For use in slide preparations of specimens for the purpose of identifying fungal elements. Dissolves epithelial cells that may mask fungi.
HARDY DIAGNOSTICS
Z78
In Commercial Distribution

  • 00819398027380 ()
Z78

  • Fixative, acid
Voges-Proskauer Reagent B, VP-B, KOH 40%, 15ml dropper vial For use in determining the Voges-Proskauer (VP) reaction of bacteria.
HARDY DIAGNOSTICS
Z92
In Commercial Distribution

  • 00819398027359 ()
Z92

  • Voges-Proskauer (VP) microbial reagent IVD
Voges-Proskauer Reagent A, VP-A, alpha Naphthol, 15ml dropper vial For use in determining the Voges-Proskauer (VP) reaction of bacteria.
HARDY DIAGNOSTICS
Z91
In Commercial Distribution

  • 00819398027281 ()
Z91

  • Voges-Proskauer (VP) microbial reagent IVD
Bile Spot Test, Deoxycholate 10%, for Streptococcus pneumoniae, rapid spot test for pneumococci, 15ml each Sodium desoxycholate 10%, use to identify S. pneumoniae, colonies will autolyze in the presence of bile salts. Store in refrigerator, warm before use. Recommended for use in presumptively differentiating bile soluble Streptococcus pneumoniae from bile insoluble alpha-hemolytic Streptococcus spp. The bile solubility test may be performed using a cell suspension or by applying the Bile Spot Reagent directly to the colony.
HARDY DIAGNOSTICS
Z61
In Commercial Distribution

  • 00819398027212 ()
Z61

  • Bile solubility microbial reagent IVD
Anaerobe Nitrate Reagent A, Sulfanilic Acid for nitrate reduction test, 15ml, formulated especially for anaerobic bacteria Hardy Diagnostics Anaerobe Nitrate Reagents A, B, and C are recommended for use in determining the nitrate reduction reaction of anaerobic bacteria. This product is to be used with Nitrate Reagent B (Cat. no. Z135)and Nitrate Reagent C (Cat. no. Z73).
HARDY DIAGNOSTICS
Z134
In Commercial Distribution

  • 00819398027199 ()
Z134

  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent
McFarland Standard, Latex Equivalent # 1, 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
ML1
In Commercial Distribution

  • 00819398027175 ()
ML1

  • McFarland standard IVD
Catalase Reagent, hydrogen peroxide 3% Hydrogen peroxide 3%, (H2O2), catalase positive organisms (such as Staphylococcus) will evolve gas bubbles in the presence of H2O2. Useful in the presumptive identification and differentiation of many bacteria. Beta-hemolytic organisms, such as Streptococcus species (catalase-negative), Staphylococcus species (catalase-positive), and Listeria species (catalase-positive) can be differentiated by their catalase reaction.
HARDY DIAGNOSTICS
Z62
In Commercial Distribution

  • 00819398027106 ()
Z62

  • Catalase production microbial reagent IVD
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
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
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
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