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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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Additional Catalog Numbers: 9002814 QIAstat-Dx Analytical Module 9002813 QIAstat-Dx Operational Module DI Numbers: QIAstat-Dx Analytical Module DI Number: 04053228033929 QIAstat-Dx Operational Module DI Number: 04053228033936
QIAGEN GmbH
v1
In Commercial Distribution

  • 04053228033936 ()
9002824

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228010838 ()
9002035

  • 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 system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution

  • 00840733102318 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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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