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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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Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Wallac Oy
5002-0500
In Commercial Distribution

  • 06438147320905 ()
5002-0500

  • Clinical laboratory information system
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Wallac Oy
5002-0180
In Commercial Distribution

  • 06438147153312 ()
5002-0180

  • Clinical laboratory information system
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
Wallac Oy
5002-0130
In Commercial Distribution

  • 06438147153275 ()
5002-0130

  • Clinical laboratory information system
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
ST401e is used for enrichment and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400120
In Commercial Distribution

  • 08885013950076 ()
400120

  • Clinical laboratory information system
Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400124
In Commercial Distribution

  • 08885013950069 ()
400124

  • Clinical laboratory information system
The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing.
VELA OPERATIONS SINGAPORE PTE. LTD.
7468
In Commercial Distribution

  • 08885013950045 ()
400103

  • Clinical laboratory information system
Broadband Oximetry Accessory, International
Respironics, Inc.
Broadband/Oximetry Accessory, Intl
In Commercial Distribution

  • 00606959021570 ()
100215E

  • Clinical laboratory information system
OmniLab Connect System
Respironics, Inc.
OmniLab Connect System
In Commercial Distribution

  • 00606959021501 ()
1111076

  • Clinical laboratory information system
Broadband Accessory and WiFi Router, USA
Respironics, Inc.
Broadband Accessory and WiFi Router, US
In Commercial Distribution

  • 00606959013971 ()
100200E

  • Clinical laboratory information system
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