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Device Description : For the qualitative determination of human chorionic gonadotropin (hCG) in serum For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.
Device Class :
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Ketone Serum Controls are intended for use with Ketone tablet tests. These cont Ketone Serum Controls are intended for use with Ketone tablet tests. These controls are for professional use.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Ketone Urine Controls is an assayed urine control intended for use in validating Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for the quantitative measurement of B-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood, and for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal whole blood.The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.The system should not be used for the diagnosis of or screening for diabetes.The EKF Diagnostics STAT-Site WB B-Ketone Test Strips are for use with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure B-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.EKF Diagnostics STAT-Site WB Blood Glucose Test Strips are for use with EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose 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, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose 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, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose 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, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes.
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