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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 Type Device Class Implantable

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Concentriq AP-Dx - 00860006054519

Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Proscia Inc.
4.5
In Commercial Distribution

  • 00860006054519 ()
US

  • Laboratory instrument/analyser application software IVD

Cologuard 2 Test Definition - 00858637005901

No Description
EXACT SCIENCES CORPORATION
1.1
In Commercial Distribution

  • 00858637005901 ()


  • Laboratory instrument/analyser application software IVD

Cologuard Test Definition v1.7 - 00858637005888

No Description
EXACT SCIENCES CORPORATION
1.7
In Commercial Distribution

  • 00858637005888 ()


  • Laboratory instrument/analyser application software IVD

Reader Control v2.2 - 00858637005833

Reader Control v2.2 for Exact Sciences System Software
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005833 ()


  • Laboratory instrument/analyser application software IVD

Cologuard Test Definition v1.6 - 00858637005826

No Description
EXACT SCIENCES CORPORATION
1.6
Not in Commercial Distribution

  • 00858637005826 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface - 00858637005413

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005413 ()


  • Laboratory instrument/analyser application software IVD

Analytical Client - 00858637005406

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005406 ()


  • Laboratory instrument/analyser application software IVD

Analytical Server - 00858637005390

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005390 ()


  • Laboratory instrument/analyser application software IVD

Cologuard Test Definition v1.4 - 00858637005352

No Description
EXACT SCIENCES CORPORATION
1.4
In Commercial Distribution

  • 00858637005352 ()


  • Laboratory instrument/analyser application software IVD

Cycler Control - 00858637005321

No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005321 ()


  • Laboratory instrument/analyser application software IVD
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