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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
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
No Description
Roche Molecular Systems, Inc.
07886985001
In Commercial Distribution

  • 07613336119570 ()
07886985001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07886977001
Not in Commercial Distribution

  • 07613336119563 ()
07886977001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07341920190
Not in Commercial Distribution

  • 07613336100097 ()
07341920190

  • 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
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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