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Portable Blood Glucose Meter with Test Strips
ARKRAY USA, INC.
741100
In Commercial Distribution
- 10015482741102 ()
- 00015482741105 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
740020
In Commercial Distribution
- 00015482740023 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
740001
In Commercial Distribution
- 10015482740013 ()
- 00015482740016 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
571100
In Commercial Distribution
- 10015482571105 ()
- 00015482571108 ()
- 20015482571102 ()
- Glucose monitoring system IVD, home-use
Portable Blood Glucose Meter
ARKRAY USA, INC.
570001
In Commercial Distribution
- 10015482570108 ()
- 00015482570101 ()
- 20015482570105 ()
- Glucose monitoring system IVD, home-use
GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
570007
In Commercial Distribution
- 00015482570071 ()
- Glucose IVD, control
GLUCOCARD Expression Level 1 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570002 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
570005
In Commercial Distribution
- 00015482570002 ()
- Glucose IVD, control
The GLUCOCARD Shine Express 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 forearm, palm, thigh and calf.
ARKRAY USA, INC.
544110
In Commercial Distribution
- 20015482544106 ()
- 10015482544109 ()
- 00015482544102 ()
- Glucose monitoring system IVD, home-use
The GLUCOCARD Shine Connex 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 forearm, palm, thigh and calf.
ARKRAY USA, INC.
543110
In Commercial Distribution
- 20015482543109 ()
- 10015482543102 ()
- 00015482543105 ()
- Glucose monitoring system IVD, home-use
The GLUCOCARD Shine XL 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 forearm, palm, thigh and calf.
ARKRAY USA, INC.
542110
In Commercial Distribution
- 20015482542102 ()
- 10015482542105 ()
- 00015482542108 ()
- Glucose monitoring system IVD, home-use