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 Class Implantable

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No Description
SD Biosensor, Inc.
99LS10-2
In Commercial Distribution

  • 08809319396789 ()
  • 08809319396512 ()


  • Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
No Description
SD Biosensor, Inc.
02LS10B
In Commercial Distribution

  • 00887473000313 ()
  • 00887473000344 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry
No Description
SD Biosensor, Inc.
02LS10C
In Commercial Distribution

  • 00887473000313 ()
  • 00887473000337 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry
No Description
SD Biosensor, Inc.
02LS10B
In Commercial Distribution

  • 00887473000313 ()
  • 00887473000306 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry
No Description
SD Biosensor, Inc.
02LS10C
In Commercial Distribution

  • 00887473000313 ()
  • 00887473000290 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry
CURO L5 Glucose Strip
KPI HEALTHCARE, INC.
Curo L5
In Commercial Distribution

  • 00850006113064 ()
  • 00850006113057 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
Total Cholesterol Strips
KPI HEALTHCARE, INC.
CURO L5 Total Cholesterol Strips
In Commercial Distribution

  • 00860394001256 ()
  • 00860394001218 ()


  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CardioChek Lipid Panel Test
HENRY SCHEIN, INC.
5700414
In Commercial Distribution

  • 10304040037741 ()
  • 00304040037744 ()
5700414

  • Multiple lipid analyte IVD, kit, spectrophotometry
CardioChek 15Lipid/15Glucose
HENRY SCHEIN, INC.
5700412
In Commercial Distribution

  • 20304040037731 ()
  • 10304040037734 ()
  • 00304040037737 ()
5700412

  • Multiple lipid analyte IVD, kit, multiple technologies
  • Multiple clinical chemistry enzyme IVD, kit, spectrophotometry
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4753
In Commercial Distribution

  • 10381934753017 ()
  • 00381934753010 ()
REF 4753

  • Multiple lipid analyte IVD, kit, spectrophotometry
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