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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 mini VIDAS is a complete standalone immunodiagnostic system using VIDAS assay kits.
BIOMERIEUX SA
99737R
In Commercial Distribution

  • 03573026152499 ()


  • Fluorescent immunoassay analyser IVD, laboratory
The mini VIDAS is a complete standalone immunodiagnostic system using VIDAS assay kits.
BIOMERIEUX SA
99737
In Commercial Distribution

  • 03573026140441 ()


  • Fluorescent immunoassay analyser IVD, laboratory
No Description
CAROLINA LIQUID CHEMISTRIES CORPORATION
CLCE1106
In Commercial Distribution

  • 00817302022339 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Semi-automated reader for RPR testomg
ARLINGTON SCIENTIFIC, INC.
NC-2400-0BT
In Commercial Distribution

  • 00816057020041 ()

  • Area/Surface Area: 1.24 Square meter
NC-2400-0BT

  • Microplate reader IVD, manual
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 2900-0101-1
In Commercial Distribution

  • 04049016159018 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use.
SANWA BIOTECH LIMITED
THETIS220
In Commercial Distribution

  • 04897078440106 ()
10103

  • Fluorescent immunoassay analyser IVD, laboratory
Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use.
SANWA BIOTECH LIMITED
ARIEL220
In Commercial Distribution

  • 04897078440052 ()
10102

  • Fluorescent immunoassay analyser IVD, laboratory
ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use.
SANWA BIOTECH LIMITED
DX320
In Commercial Distribution

  • 04897078440045 ()
10101

  • Fluorescent immunoassay analyser IVD, laboratory
The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.21
In Commercial Distribution

  • 04987669200780 ()


  • Corneal topography system
The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.
NIDEK CO.,LTD.
1.20
In Commercial Distribution

  • 04987669100844 ()


  • Corneal topography system
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