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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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No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-IF1000
In Commercial Distribution

  • 06974849369380 ()


  • Fluorescent immunoassay analyser IVD, laboratory
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS IF 100
In Commercial Distribution

  • 06974849369298 ()


  • Fluorescent immunoassay analyser IVD, laboratory
No Description
Shenzhen Superbio Technology Co., Ltd.
EASY-11
In Commercial Distribution

  • 06974521006626 ()
YRLE01106

  • Fluorescent immunoassay analyser IVD, laboratory
No Description
Shenzhen Superbio Technology Co., Ltd.
EASY-11
In Commercial Distribution

  • 06974521002246 ()
SUPE01106

  • 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
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
3
In Commercial Distribution

  • EIBA120131231 ()
  • EIBA120131230 ()
120-131OEM CAN

  • Diagnostic x-ray system quality assurance device
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131221 ()
  • EIBA120131220 ()
120-131OEM CAN

  • Diagnostic x-ray system quality assurance device
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
1
In Commercial Distribution

  • EIBA120131210 ()
  • EIBA120131211 ()
120-131OEM CAN

  • Diagnostic x-ray system quality assurance device
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