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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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BIOER GeneExplorer Thermal Cycler - 06973843220420

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-48D
In Commercial Distribution

  • 06973843220420 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOER GeneExplorer Thermal Cycler - 06973843220390

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-4I
In Commercial Distribution

  • 06973843220390 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOER GeneExplorer Thermal Cycler - 06973843220383

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-384G
In Commercial Distribution

  • 06973843220383 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOER GeneExplorer Thermal Cycler - 06973843220376

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-48DS
In Commercial Distribution

  • 06973843220376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOER GeneExplorer Thermal Cycler - 06973843220277

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-96G
In Commercial Distribution

  • 06973843220277 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Q-Vera Prima 96 qPCR Instrument - 06955792700864

For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Sansure Biotech Inc.
96-well, 0.2 mL block
In Commercial Distribution

  • 06955792700864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Idylla™ System - 05415219000126

The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
Biocartis NV
Idylla™ Console
In Commercial Distribution

  • 05415219000126 ()
P1010

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Idylla™ System - 05415219000119

Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
Biocartis NV
Idylla™ Instrument
In Commercial Distribution

  • 05415219000119 ()
P0010

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Acuitas - 04260364751017

QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Unyvero - 04260364750003

Instrument to process 2 Unyvero Cartridges
Curetis GmbH
A50 Analyzer
Not in Commercial Distribution

  • 04260364750003 ()
60001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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