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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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KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-6010
In Commercial Distribution

  • D77819960101 ()

  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
199-6010

  • Dental composite resin
Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per package New Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk! The rapid Nitrocef test consists of a paper match-stick that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms: • Neisseria gonorrhoeae • Haemophilus spp. • Moraxella (Branhamella) catarrhalis • Staphylococcus spp. • Enterococcus spp. • Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella) The rapid Nitrocef MatchBookTM can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. Now contains a larger reaction pad.
HARDY DIAGNOSTICS
Z108
Not in Commercial Distribution

  • 00819398027526 ()
  • 00819398028547 ()
Z108

  • Beta-lactamase detection reagent IVD
ONPG-PDA, for rapid lactose fermentation and phenylalanine deaminase detection, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 To aid in the rapid identification of Salmonella and Shigella spp. in clinical specimens. Detects beta-galactosidase and phenylalanine deaminase activity.
HARDY DIAGNOSTICS
R93
In Commercial Distribution

  • 00819398023740 ()
  • 00819398023757 ()
R93

  • Differential/selective broth culture medium IVD
ONPG, Rapid Test Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the rapid determination of beta-Galactosidase activity of gram negative bacilli.
HARDY DIAGNOSTICS
R92
In Commercial Distribution

  • 00819398023726 ()
  • 00819398023733 ()
R92

  • Differential/selective broth culture medium IVD
Schiff's Reagent for Histological Staining
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • SO429852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce
SO-429

  • Biological stain IVD
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
Not in Commercial Distribution

  • 10856626006189 ()
  • 00856626006182 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
Not in Commercial Distribution

  • 10856626006172 ()
  • 00856626006175 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
Not in Commercial Distribution

  • 10856626006134 ()
  • 00856626006137 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
Not in Commercial Distribution

  • 10856626006073 ()
  • 00856626006076 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
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