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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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PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD

MULTIVIEW - 15420045504684

MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD

SecurView Diagnostic Workstation - 15420045504523

The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis.
Hologic, Inc.
SecurView DX
In Commercial Distribution

  • 15420045504523 ()


  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051300

Alinity m EBV Application Specification File
ABBOTT MOLECULAR INC.
09N43-05B
In Commercial Distribution

09N43-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051096

Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03B
In Commercial Distribution

09N17-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051065

Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05B
In Commercial Distribution

09N46-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050945

Alinity m BKV Application Specification File
ABBOTT MOLECULAR INC.
09N85-05A
In Commercial Distribution

  • 00884999050945 ()
09N85-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050860

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03B
In Commercial Distribution

  • 00884999050860 ()
08N50-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050853

Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03C
In Commercial Distribution

  • 00884999050853 ()
08N45-03C

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050570

Alinity m HSV 1 & 2 / VZV Application Specification File
ABBOTT MOLECULAR INC.
09N61-03A
In Commercial Distribution

  • 00884999050570 ()
09N61-03A

  • Laboratory instrument/analyser application software IVD
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