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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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NeoEldex ELISA Analyzer - 00816870020051

No Description
MONOBIND, INC.
IN009
In Commercial Distribution

  • 00816870020051 ()
IN009

  • Enzyme immunoassay (EIA) analyser IVD

Titin-s ELISA & CLIA Analyzer - 00816870024011

No Description
MONOBIND, INC.
IN016-EC
In Commercial Distribution

  • 00816870024011 ()
IN016-EC

  • Multi-modality clinical specimen analysis system IVD

Titin ELISA & CLIA Analyzer - 00816870023991

No Description
MONOBIND, INC.
IN015-EC
In Commercial Distribution

  • 00816870023991 ()
IN015-EC

  • Multi-modality clinical specimen analysis system IVD

Autoplex G2 ELISA + CLIA Analyzer - 00816870020082

No Description
MONOBIND, INC.
IN006-2
In Commercial Distribution

  • 00816870020082 ()
IN006-2

  • Multi-modality clinical specimen analysis system IVD

PrisMatic ELISA Analyzer - 00816870020068

No Description
MONOBIND, INC.
IN013
In Commercial Distribution

  • 00816870020068 ()
IN013

  • Enzyme immunoassay (EIA) analyser IVD

Autoplex G3 ELISA + CLIA Analyzer - 00816870024448

No Description
MONOBIND, INC.
IN006-3
In Commercial Distribution

  • 00816870024448 ()
IN006-3

  • Multi-modality clinical specimen analysis system IVD

ProTube - 07640172343012

ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343012 ()


  • Specimen information management system IVD

ProTube - 07640172343005

The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343005 ()


  • Specimen information management system IVD

PTS Connect™ Universal Solution - 00381933771015

The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.
POLYMER TECHNOLOGY SYSTEMS, INC.
3771
In Commercial Distribution

  • 00381933771015 ()
3771

  • Clinical laboratory information system

HELMED - 04260186125003

Automated IFA Processor
Aesku.Systems GmbH & Co. KG
HELMED IFA PROCESSOR KIT
In Commercial Distribution

HEL-1000

  • Multi-modality clinical specimen analysis system IVD
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