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The Atellica® CH Diazo Direct Bilirubin (D DBil) assay is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma using the Atellica® CH Analyzer. Measurement of direct bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic-hematological, and metabolic disorders, including hepatitis and gall bladder block.

Atellica® CH Diazo Direct Bilirubin is a Photometric test using 2,4-dichloroaniline (DCA). Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution. Absorbance is measured at 545/658 nm.

The Atellica® CH Diazo Total Bilirubin (D TBil) assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in adults and children (non-neonates) in human serum and plasma using the Atellica® CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Atellica CH Diazo Total Bilirubin is a photometric test using 2,4-dichloroaniline (DCA). Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables the determination of the total bilirubin.

The Total Bilirubin2 assay is used for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c System. Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and disorders of the biliary tract. In newborn infants, the Total Bilirubin2 assay is intended to measure the levels of total bilirubin (conjugated and unconjugated) in serum or plasma to aid in the diagnosis and management of neonatal jaundice and hemolytic disease of the newborn.

The Total Bilirubin2 assay (subject device) is an automated clinical chemistry assay for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c System. Total (conjugated and unconjugated) bilirubin couples with a diazo reagent in the presence of a surfactant to form azobilirubin. The diazo reaction is accelerated by the addition of surfactant as a solubilizing agent. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration. The methodology is Diazonium salt.

Rx Only For in vitro diagnostic use only The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

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ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only. Each kit consists of a bi-reagent R1 & R2. ELITech Clinical Systems BILIRUBIN TOTAL 4+1: Reagent 1: R1 Sulphanilic acid 29 mmol/L, Cetrimide 29 mmol/L. Reagent 2: R2 Sodium nitrite 11 mmol/L. ELITech Clinical Systems BILIRUBIN DIRECT 4+1: Reagent 1: R1 Sulphanilic acid 29 mmol/L, Reagent 2: R2 Sodium nitrite 11 mmol/L.

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 System. Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

The Total Bilirubin reagent kit contains Reagent 1 and Reagent 2. Reagent 1 contains Surfactants and HCl. Reagent 2 contains 2, 4-dichloroaniline, HCl, Sodium nitrite, and Surfactant. The principles of the procedure involve total (conjugated and unconjugated) bilirubin coupling with a diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration. The detection of the analyte is end-point colorimetric.

cobas c Bilirubin Total Gen.3 is an in vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. Measurement of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

cobas c Bilirubin Total Gen.3 reagent provides quantitative measurement of the total bilirubin that is present in serum and plasma of adults and neonates. Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R1 contains detergent, buffer, and stabilizers at pH 1.0. R2 is a 3,5-dichlorophenyl diazonium salt: ≥ 1.35 mmol/L.

The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma using the Hitachi Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Total Billirubin measurements are used in the diagnosis and treatment of disorders of the liver.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Total Bilirubin. Chemistry reaction: Nitrous acid method: Total bilirubin in samples is oxidized to biliverdin by the action of nitrous acid at pH 3.7. The concentration of total bilirubin can be determined by measuring the decrease of absorbance at a wavelength of 450nm .

The EasyRA TBIL reagent is intended for the quantitative measurement of Total Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only. The EasyRA DBIL reagent is intended for the quantitative measurement of Direct Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only. The EasyRA CK reagent is intended for the quantitative determination of Creatine Kinase (CK) in human serum and plasma, using the MEDICA "EasyRA Chemistry analyzer" in clinical laboratories. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only.

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COBAS INTEGRA Bilirubin Direct Gen.2 is an in vitro test for the quantitative determination of direct bilirubin in human serum and plasma on COBAS INTEGRA systems. Measurement of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

COBAS INTEGRA Bilirubin Direct Gen.2 reagent provides quantitative measurement of the direct bilirubin that is present in a human serum or human plasma sample. Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 and SR. R1, or Reagent 1, contains Phosphoric acid 85 mmol/L, NaCl 50 mmol/L, and HEDTA 4.0 mmol/L at pH 1.9. SR, or Start Reagent, is a 3,5-dichlorophenyl diazonium salt at 1.5 mmol/L in acid buffer, pH 1.3.