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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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The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 28055182872354 ()
  • 08055182872350 ()
  • 18055182872357 ()
$92070-1

  • Plazomicin minimum inhibitory concentration (MIC) IVD
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9245
In Commercial Distribution

  • 00816576021086 ()
  • 00816576021819 ()
Z9245

  • Vancomycin susceptibility testing disc IVD
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9241
In Commercial Distribution

  • 00816576021079 ()
  • 00816576021819 ()
Z9241

  • Vancomycin susceptibility testing disc IVD
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution

  • 05906874392027 ()


  • Eye movement analysis system
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution

  • 05906874392010 ()


  • Eye movement analysis system
NewPort Rod Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
NWPRIMP
In Commercial Distribution

  • 10889981028220 ()
NWPRIMP

  • Vertebral body prosthesis, non-sterile
S2S CrossBar, 33 - 47mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2023
Not in Commercial Distribution

  • 10889910059165 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, non-sterile
The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
YD Diagnostics CORP.
Optima
In Commercial Distribution

  • 08806125619033 ()


  • Urine analyser IVD, laboratory, semi-automated
The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-E can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800365
In Commercial Distribution

  • 03661540951442 ()
800365

  • Exogenous RNA internal control kit IVD
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