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
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450871111 ()
87111

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450867657 ()
86765

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000047 ()
86765

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000030 ()
87111

  • Laboratory instrument/analyser application software IVD
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD
The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD
No Description
DIASORIN SPA
Q0001
In Commercial Distribution

  • 08056771103572 ()


  • 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
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