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For the quantitative determination of creatine kinase activity in serum and plasma. Rx only. Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infaction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

The Pointe Scientific Creatine Kinase (CK) Reagent Set consists of ready-to-use liguid reagents: - . CK R1 (buffer) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L; NADP 2.0 mmol/L: HK (Baker's yeast) 2.5 KU/L: Glucose 20.0 mmol/L: Magnesium Acetate 10.0 mmol/L; EDTA 2.0 mmol/L and N-acetylcysteine (NAC) 20.0 mmol/L. - . CK R2 (enzyme reagent) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L: ADP 2.0 mmol/L: AMP 5.0 mmol/L: Diadensosine pentaphosphate 10.0 mmol/L: Creatine phosphate 30.0 mmol/L; G6PDH (Baker's yeast) 1.5 KU/L and EDTA 2.0 mmol/L. The kinetic procedure presented is a modification of Szasz of the Rosalki technique, which optimizes the reaction by reactivation of CK activity with N-actyl-L-cysteine (NAC). Creatine Kinase specifically catalyzes the transphosphorylation of ADP to ATP. Through a series of coupled enzymatic reactions, NADPH is produced at a rate directly proportional to the CK activity. The method determines the NADPH absorbance increase per min at 340 nm.

For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately. The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.

ADVIA Chemistry® Creatine Kinase (CK_L) Assay: The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. ADVIA Chemistry® Enzyme 3 Calibrator: ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK L) assay on the ADVIA Chemistry systems.

ADVIA Chemistry Creatine Kinase (CK L) assay is a ready-to-use liquid reagent packaged for use on the automated ADVIA Chemistry systems. Creatine Kinase reacts with creatine phosphate and ADP to form adenosine triphosphate (ATP), which is coupled to the hexokinase-G6PD reaction, generating NADPH. The concentration of NADPH is measured by the increase in absorbance at 340/596 nm. ADVIA Chemistry ENZ 3 CAL: ENZ 3 CAL is a liquid frozen human serum albumin based product containing creatine kinase MM from human heart. Enzyme 3 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required).

Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola. Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods. The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.

Liquid CK-MB is supplied in a kit containing: - 4 x 20.0 mL CK-MB Buffer - 4 x 6.0 mL CK-MB Substrate. The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.

Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Vital Diagnostics CPK Reagent

The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine-diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm. Dimension Vista® (MBI) Flex® Reagent Cartridge (K2032): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.

Dimension® (CKI) Flex® Reagent Cartridge (DF38): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting qlucose-6-phosphate is oxidized by qlucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm. Dimension® (MBI) Flex® Reagent Cartridge (DF32): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose_The resulting glucose-6-phosphate is oxidized by glucose-6phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample. CKI/MBI Calibrator (DC32): CKI/MBI CAL is a liquid, multi-analyte, human serum albumin based product containing creatine kinase (human source) and creatine kinase MB (porcine source). The kit consists of four vials per level (2 and3) with 2.0 mL per vial. Level 1 calibrator for CKI/MBI is not included in the CKI/MBI CAL carton. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Creatine Kinase Liquid Reagent (Kinetic Method)

Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes. ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy. The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods. ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay. Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease. The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin. The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml. The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml. The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml. The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.