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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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RealTime - 00884999037113

Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0
ABBOTT MOLECULAR INC.
06L98-05
In Commercial Distribution

  • 00884999037113 ()
06L98-05

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999034266

Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
ABBOTT MOLECULAR INC.
08L21-01
In Commercial Distribution

  • 00884999034266 ()
08L21-01

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045513976

72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, LARGE
In Commercial Distribution

  • 15420045513976 ()
ASY-14451

  • Microscope slide digital imaging scanner IVD
  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045513921

32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, BASE
In Commercial Distribution

  • 15420045513921 ()
ASY-14305

  • Laboratory instrument/analyser application software IVD
  • Microscope slide digital imaging scanner IVD
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