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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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Alinity - 00380740143404

Alinity c Phenytoin Assay File
Abbott GmbH
08P541A
In Commercial Distribution

  • 00380740143404 ()
08P541A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143367

Alinity c LacticAcid Assay File
Abbott GmbH
08P211A
In Commercial Distribution

  • 00380740143367 ()
08P211A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740143350

Alinity c Gentamicin Assay File
Abbott GmbH
08P551A
In Commercial Distribution

  • 00380740143350 ()
08P551A

  • Laboratory instrument/analyser application software IVD

LIFECODES MATCH IT! Antibody Software - 10888234500810

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution

  • 10888234500810 ()
888627

  • Laboratory instrument/analyser application software IVD

LIFECODES MATCH IT!™ DNA Software v1.3 - 10888234500803

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
In Commercial Distribution

  • 10888234500803 ()
888623

  • Laboratory instrument/analyser application software IVD

twiist - 00198617904009

twiist Refill Kit without Infusion Set
SEQUEL MED TECH, LLC
RF-90400
In Commercial Distribution

  • 00198617904009 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00198617901008

twiist Refill Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
RF-90100
In Commercial Distribution

  • 00198617901008 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00198617101002

twiist Convenience Starter Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
CM-10100
In Commercial Distribution

  • 00198617101002 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

BD FACSuite - 00382906630070

BD FACSuite™ Clinical BD Multitest™ 6-Color Assays v1.0
Becton, Dickinson And Company
663007
In Commercial Distribution

  • 00382906630070 ()
663007

  • Laboratory instrument/analyser application software IVD

FACSVia - 00382906605610

BD FACSVia™ Clinical Software, Test Definitions, and Documentation v1.2
Becton, Dickinson And Company
660561
In Commercial Distribution

  • 00382906605610 ()
660561

  • Laboratory instrument/analyser application software IVD
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