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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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QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640123 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640116 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640024 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640017 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 01812125010067 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
09260994001
In Commercial Distribution

  • 07613336179970 ()
09260994001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
08415129001
Not in Commercial Distribution

  • 07613336156926 ()
08415129001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
08276412001
In Commercial Distribution

  • 07613336148259 ()
08276412001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
08153248001
Not in Commercial Distribution

  • 07613336142738 ()
08153248001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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