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
2.0
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
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
No Description
Roche Diagnostics GmbH
09220763001
In Commercial Distribution

  • 07613336192429 ()
09220763001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08403864001
Not in Commercial Distribution

  • 07613336156551 ()
08403864001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution

  • 07613336156544 ()
08403856001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08302375001
Not in Commercial Distribution

  • 07613336150047 ()
08302375001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD
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