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The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
ARKRAY USA, INC.
541100
In Commercial Distribution
- 10015482541009 ()
- 00015482541002 ()
- 20015482541006 ()
- Glucose monitoring system IVD, home-use
The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
ARKRAY USA, INC.
540001
In Commercial Distribution
- 10015482540019 ()
- 00015482540012 ()
- 20015482540016 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
530001
In Commercial Distribution
- 20015482530017 ()
- 00015482530013 ()
- 30015482530014 ()
- Glucose monitoring system IVD, home-use
The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. For single-patient use only.
ARKRAY USA, INC.
511100
Not in Commercial Distribution
- 10015482511101 ()
- 00015482511104 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
500001
In Commercial Distribution
- 20015482500010 ()
- 00015482500016 ()
- Glucose monitoring system IVD, home-use
FPPL Select Brand SPS +/-
L. & R. DISTRIBUTORS, INC.
One Step Pregnancy Test
Not in Commercial Distribution
- 10015127007266 ()
- 00015127007269 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Blood Glucose Meter, Agamatrix, AMP, mg/dL
AGAMATRIX, INC.
8000-04063
In Commercial Distribution
- 10385544063016 ()
- Glucose monitoring system IVD, home-use
Test Strips, AgaMatrix, AMP, 50CT
AGAMATRIX, INC.
8000-04034
In Commercial Distribution
- 30385544036014 ()
- 20385544036017 ()
- 00385544036013 ()
- 10385544034016 ()
- 80385544034015 ()
- Glucose monitoring system IVD, home-use
Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL
AGAMATRIX, INC.
8000-03909
In Commercial Distribution
- 10385543909018 ()
- Glucose monitoring system IVD, home-use
Test Strips, AgaMatrix, Presto, 50CT
AGAMATRIX, INC.
8000-03334
In Commercial Distribution
- 30385543337013 ()
- 20385543337016 ()
- 00385543337012 ()
- 10385543334018 ()
- 30385543329018 ()
- 20385543329011 ()
- 00385543329017 ()
- 80385543334017 ()
- Glucose monitoring system IVD, home-use