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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Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2882
In Commercial Distribution

  • 40301932882213 ()
  • 00301932882215 ()
  • 10301932882212 ()
  • 0193-2882-21 ()
  • 00301932882017 ()
15197

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
2881
In Commercial Distribution

  • 40301932881216 ()
  • 00301932881218 ()
  • 10301932881215 ()
  • 0193-2880-21 ()
  • 00301932881010 ()
5778865

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
2880
In Commercial Distribution

  • 40301932880509 ()
  • 00301932880501 ()
  • 10301932880508 ()
  • 0193-2880-50 ()
  • 00301932880013 ()
9549534

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Reagent strips for urinalysis - glucose. 50 test strips.
ASCENSIA DIABETES CARE US INC.
2806
In Commercial Distribution

  • 40301932806509 ()
  • 00301932806501 ()
  • 10301932806508 ()
  • 0193-2802-50 ()
  • 00301932806013 ()
8488841

  • Urine glucose IVD, kit, rapid colorimetric, clinical
Reagent strips for urinalysis - glucose. 100 test strips.
ASCENSIA DIABETES CARE US INC.
2803
In Commercial Distribution

  • 40301932803218 ()
  • 00301932803210 ()
  • 10301932803217 ()
  • 0193-2802-21 ()
  • 00301932803012 ()
2871538

  • Urine glucose IVD, kit, rapid colorimetric, clinical
Control Solution - High, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1491A
Not in Commercial Distribution

  • 50301931491017 ()
  • 40301931491010 ()
  • 00301931491012 ()
  • 10301931491019 ()
  • 0193-1491-01 ()
81007218

  • Glucose IVD, control
Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1490A
Not in Commercial Distribution

  • 50301931490010 ()
  • 40301931490013 ()
  • 00301931490015 ()
  • 10301931490012 ()
  • 0193-1490-01 ()
81007196

  • Glucose IVD, control
Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1489A
Not in Commercial Distribution

  • 50301931489014 ()
  • 40301931489017 ()
  • 00301931489019 ()
  • 10301931489016 ()
  • 0193-1489-01 ()
81007188

  • Glucose IVD, control
Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
ASCENSIA DIABETES CARE US INC.
1466A
Not in Commercial Distribution

  • 00301931466218 ()
  • 10301931466215 ()
  • 20301931466212 ()
  • 0193-1466-21 ()
  • 00301931466010 ()
  • 40301931466216 ()
56853220

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1468A
Not in Commercial Distribution

  • 40301931468500 ()
  • 00301931468502 ()
  • 10301931468509 ()
  • 20301931468506 ()
  • 0193-1468-50 ()
  • 00301931468014 ()
56853247

  • Glucose monitoring system IVD, home-use
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