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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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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
No Description
Roche Diagnostics GmbH
05524245001
Not in Commercial Distribution

  • 04015630935406 ()
05524245001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Diagnostics GmbH
05412722001
Not in Commercial Distribution

  • 04015630935390 ()
05412722001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
05200881001
Not in Commercial Distribution

  • 04015630929016 ()
05200881001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
03121453001
In Commercial Distribution

  • 04015630925537 ()
03121453001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
03279332001
In Commercial Distribution

  • 04015630924745 ()
03279332001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
ELITECHGROUP SPA
INT030-K
In Commercial Distribution

  • 03661540900006 ()
INT030-K

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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