STANBIO LABORATORY, L.P.

GUDID#

Procalcitonin LiquiColor - Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.

2017-06-26

Albumin LiquiColor® - For the Quantitative Colorimetric Determination of Albumin in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Sirrus® Albumin LiquiColor® - For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

STANBIO LABORATORY, L.P.

2016-09-23

Glycated Serum Protein (GSP) LiquiColor® - Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients.

STANBIO LABORATORY, L.P.

2016-09-23

STAT-Site WB Dual Analyte Measurement System - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB Blood Glucose Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB Blood Glucose Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB Blood Glucose Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB B-Ketone Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB B-Ketone Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

STAT-Site WB B-Ketone Test Strips - 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.

STANBIO LABORATORY, L.P.

2019-11-18

Blood Glucose Control Solution - 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.

STANBIO LABORATORY, L.P.

2019-11-18

B-Ketone Control Solution - 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.

STANBIO LABORATORY, L.P.

2019-11-18

Acetaminophen Liquicolor® - For the In Vitro Quantitative Determination of Acetaminophen in Serum.

STANBIO LABORATORY, L.P.

2016-09-23

Alkaline Phosphatase LiquiColor® - For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

Alkaline Phosphatase LiquiColor® - For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

a-Amylase LiquiColor® - For the Quantitative Determination of Amylase in Serum and Urine.

STANBIO LABORATORY, L.P.

2016-09-23

AST/SGOT Liqui-UV® - For the Kinetic Quantitative Determination of AST/GOT in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

AST/SGOT Liqui-UV® - For the Kinetic Quantitative Determination of AST/GOT in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

B-Hydroxybutyrate LiquiColor® - For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® - For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Direct Bilirubin LiquiColor® - For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Total Bilirubin LiquiColor® - For the Quantitative Colorimetric Determination of Total Bilirubin in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Total & Direct Bilirubin LiquiColor® - For the Quantitative Colorimetric Determination of Total and Direct Bilirubin in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Calcium (Arsenazo) LiquiColor® - For the Quantitative Colorimetric determination of Total Calcium in serum.

STANBIO LABORATORY, L.P.

2016-09-23

Calcium (CPC) LiquiColor® - For the Quantitative Colorimetric determination of Total Calcium in serum, plasma or urine.

STANBIO LABORATORY, L.P.

2016-09-24

Chloride LiquiColor® - Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF.

STANBIO LABORATORY, L.P.

2016-09-23

Cholesterol LiquiColor® - For the Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Cholesterol LiquiColor® - For the Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Direct HDL Cholesterol LiquiColor® - For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

STANBIO LABORATORY, L.P.

2016-09-23

Direct HDL Cholesterol LiquiColor® - For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

STANBIO LABORATORY, L.P.

2016-09-23

Direct HDL Cholesterol LiquiColor® - For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

STANBIO LABORATORY, L.P.

2016-09-23

Direct LDL Cholesterol LiquiColor® - For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol in Human Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

CK-MB Test - For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

Gamma-GT LiquiColor® - For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

Gamma-GT LiquiColor® - For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

2016-09-23

Glucose Liqui-UV® - For the Quantitative Determination of Glucose in Serum or Plasma.

STANBIO LABORATORY, L.P.

2016-09-23

Glucose LiquiColor® - For the Quantitative Determination of Glucose in Serum, Plasma or CSF.

STANBIO LABORATORY, L.P.

2016-09-23

Glucose LiquiColor® - For the Quantitative Determination of Glucose in Serum, Plasma or CSF.

STANBIO LABORATORY, L.P.

2016-09-23

Glucose LiquiColor® - For the Quantitative Determination of Glucose in Serum, Plasma or CSF.

STANBIO LABORATORY, L.P.

2016-09-23

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