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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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The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.
Meridian Bioscience Canada Inc
610210
In Commercial Distribution

  • 00628055344100 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
GenePoc Inc
130840
In Commercial Distribution

  • 00628055344001 ()
130840

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Disposable ventilator circuit/ tubing (Without heated wire)
VADI MEDICAL TECHNOLOGY CO., LTD.
G-316002
In Commercial Distribution

  • 14719894380923 ()
  • 04719894380926 ()
G-316002-CFS

  • Ventilator breathing circuit, single-use
The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB06HPR
In Commercial Distribution

  • 10848530090606 ()
  • 00848530090609 ()


  • Heated respiratory humidifier
Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB006SSRP
In Commercial Distribution

  • 00848530070670 ()


  • Heated respiratory humidifier
KIT, ACCESSORIES, EMV+, MILITARY,W/ MASIMO, BERRY COMPLIANT
Zoll Medical Corporation
499-0002-01-30
In Commercial Distribution

  • 00847946092863 ()


  • Ventilator breathing circuit, single-use
PADDED CASE, TAN, ADULT/PEDIATRIC AND INFANT CIRCUITS, BERRY COMPLIANT
Zoll Medical Corporation
499-0001-01-30
In Commercial Distribution

  • 00847946092856 ()


  • Ventilator breathing circuit, single-use
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
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