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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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Menopause Test - 1 Test
SYNTRON BIORESEARCH, INC.
Midstream
In Commercial Distribution

  • 10748349000707 ()
  • 00748349000700 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
CURO A1c Monthly Check Cartridge
KPI HEALTHCARE, INC.
CURO A1c
In Commercial Distribution

  • 00850006113026 ()
  • 00850006113019 ()


  • 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
CURO A1c Daily Check Cartridge
KPI HEALTHCARE, INC.
CURO A1c
In Commercial Distribution

  • 00850006113040 ()


  • 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
Curo A1c Test Cartridge
KPI HEALTHCARE, INC.
CURO A1c
In Commercial Distribution

  • 00850006113033 ()
  • 00850006113002 ()


  • 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
CURO Glucose Strips for G6 and G6s
KPI HEALTHCARE, INC.
CURO Glucose Strips
In Commercial Distribution

  • 00860394001294 ()
  • 00860394001287 ()


  • 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
Curo A1c Analyzer
KPI HEALTHCARE, INC.
Curo A1c Analyzer
In Commercial Distribution

  • 00860394001270 ()


  • 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
CURO G6 Glucose Meter
KPI HEALTHCARE, INC.
CURO G6 Glucose Meter
In Commercial Distribution

  • 00860394001263 ()


  • 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
CURO G6s Smart Glucose Meter
KPI HEALTHCARE, INC.
CURO G6s Smart Glucose Meter
In Commercial Distribution

  • 00860394001249 ()


  • 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
CURO B3 Blood Pressure Monitor
KPI HEALTHCARE, INC.
CURO B3
In Commercial Distribution

  • 00860394001232 ()


  • 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
No Description
Roche Diagnostics GmbH
11447475160
In Commercial Distribution

  • 00365702456105 ()
11447475160

  • Glucose IVD, kit, colorimetric dipstick, rapid
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