Address:1261 NORTH MAIN ST.,Boerne,TX,78006,US
Device Description : The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with th The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with th The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood G Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : Our B-Ketone Control Solution is intended for use to ensure your meter and test Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are working together properly. Use with EKF Diagnostics' B-Ketone Test Strips only.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes