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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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AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585
HARDY DIAGNOSTICS
Z121
In Commercial Distribution

  • 00819398028608 ()
Z121

  • Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid
● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device.
WELL-LIFE HEALTHCARE LTD.
WL-2407
Not in Commercial Distribution

  • 04719872264071 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Dentsply De Trey GmbH
60620101
In Commercial Distribution

  • D010606201011 ()
  • D010606201010 ()

  • Weight: 8 Gram
  • Paste
  • Powder
  • Weight: 10 Gram
60620101

  • Endodontic filling/sealing material
AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Dentsply De Trey GmbH
60620002
In Commercial Distribution

  • D010606200021 ()

  • Paste
  • Weight: 10 Gram
60620002

  • Endodontic filling/sealing material
a device for stopping the flow of blood through a vein or artery, typically by compressing a limb with a cord or tight bandage.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433229 ()
  • 00850014433222 ()
  • 20850014433226 ()

  • Length: 18 Inch
  • Width: 1 Inch
DU2210

  • Limb tourniquet, manual, single-use
The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.
TOMEY CORPORATION.
FT-1000
In Commercial Distribution

  • 04582273612150 ()


  • Ophthalmic tonometer, line-powered
The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact measurement system Air puff gently measures the intraocular pressure of the human eye.
TOMEY CORPORATION.
FT-1000
In Commercial Distribution

  • 04582273611740 ()


  • Ophthalmic tonometer, line-powered
Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
HACH COMPANY
811905
In Commercial Distribution

  • 00851575007075 ()
  • 00851575007037 ()

  • Length: 3.25 Inch
  • Width: 0.2 Inch
821971

  • Hydrogen peroxide device disinfectant/sterilant test strip
Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
HACH COMPANY
811905
In Commercial Distribution

  • 00851575007044 ()
  • 00851575007037 ()

  • Width: 0.2 Inch
  • Length: 3.25 Inch
811905

  • Hydrogen peroxide device disinfectant/sterilant test strip
RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
751110
In Commercial Distribution

  • 00840733103476 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control
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