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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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*THS ONLY* Heated Bi-PAP Setup Kit
BOUND TREE MEDICAL, LLC
670186-KIT
In Commercial Distribution

  • 00812277036237 ()
  • 00810094571245 ()
670186-KIT

  • Heated respiratory humidifier
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWSI-02
In Commercial Distribution

  • 16974900600091 ()
  • 26974900600104 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWM-02
In Commercial Distribution

  • 16974900600039 ()


  • 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
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
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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