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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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dIFine ANCA Classifier - 08059304340239

No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution

  • 08059304340239 ()


  • Laboratory instrument/analyser application software IVD

dIFine DNA Classifier - 08059304340222

No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution

  • 08059304340222 ()


  • Laboratory instrument/analyser application software IVD

dIFine ANA HEp-2 Classifier - 08059304340215

No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution

  • 08059304340215 ()


  • Laboratory instrument/analyser application software IVD

Acuitas - 01812125010081

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

QVCAD System Installation Kit - B630QVCSIK1202346

Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010344

Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010343

Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution

  • B630QVCSIK1010343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS343

No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution

  • B630QVCS343 ()


  • Ultrasound imaging system application software
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