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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No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005321 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.3
Not in Commercial Distribution

  • 00858637005277 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005246 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005239 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005222 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005215 ()


  • Laboratory instrument/analyser application software IVD
Software
Fujirebio Diagnostics, Inc.
CL0012
In Commercial Distribution

  • 00869164000048 ()


  • Laboratory instrument/analyser application software IVD
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Fujirebio Diagnostics, Inc.
404-10US
In Commercial Distribution

  • 00869164000024 ()


  • Laboratory instrument/analyser application software IVD
Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD
Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 01812125010081 ()
CP3511

  • Laboratory instrument/analyser application software IVD
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