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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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IVD Instrument (FilmArray® Torch System Base).
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0104
In Commercial Distribution

  • 00815381020253 ()
HTFA-ASY-0104

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001
In Commercial Distribution

  • 00815381020055 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
Not in Commercial Distribution

  • 00815381020048 ()
FLM2-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
In Commercial Distribution

  • 00815381020031 ()
FLM2-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020024 ()
FLM1-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Instrument)
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020017 ()
FLM1-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from biological specimens. The QIAcuityDx® Four is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228048770 ()
911060

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228047582 ()
9002828

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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