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For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. Measurement of total bilirubin, an organic compound formed 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. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

The ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) reagents are liquid ready to use. They are packaged as a kit with two kit sizes available as follows. Kit Size – 70 mL Wedge Reagent 1 and 70 mL Reagent 2 Wedge Reagent 1: 4 wedges x 68 mL Reagent 2: 4 wedges x 25 mL Kit Size - 40 mL Reagent 1 and 20 mL Reagent 2 Wedge Reagent 1: 4 wedges x 38 mL Each reagent kit consists of reagents of components and concentrations summarized below. Reagent 1: Citrate buffer, pH 2.9 (0.1 mol/L); Detergent Reagent 2: Phosphate buffer, pH 7.0 (10mmol/L); Sodium metavanadate (4 mmol/L)

The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hematological and metabolic disorders including hepatitis and gall bladder block. This device is for prescription use only.

The Randox Direct Bilirubin kit consists of ready to use reagent solutions. CATALOGUE NUMBER: BR8308 COMPONENTS: R1. 4 x 20ml, R2. 4 x 8ml REAGENT COMPOSITION R1. Direct Bilirubin RI Tartrate buffer, pH2.9 Detergent Antimicrobials and Preservatives Inhibitors Initial Concentration of Solutions 0.1 mol/L R2. Direct Bilirubin R2 Phosphate buffer, pH 7.0 Sodium Metavanadate Initial Concentration of Solutions 10 mmol/L 4 mmol/L

For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis. This in vitro diagnostic device is intended for prescription use only.

The Total Bilirubin kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: BR8307 R1. Total Bilirubin R1 4 x 20 mL R2. Total Bilirubin R2 4 x 8 mL REAGENT COMPOSITION Contents Initial Concentration of Solutions R1. Total Bilirubin R1 Citrate buffer, pH2.9 0.1 mol/L Detergent 0.9% Antimicrobial R2. Total Bilirubin R2 Phosphate buffer, pH 7.0 10 mmol/L Sodium Metavanadate 4 mmol/L MATERIALS REQUIRED BUT NOT PROVIDED Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # k942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # k053153 RX series Saline (Cat. No. SA 8396)

For in vitro diagnostic use in the quantitative determination of total billrubin in human serum and plasma on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.

The ADVIA Chemistry Total Bilirubin_2 is used for the in vitro quantitative determination of total bilirubin in human serum and plasma on the ADVIA® Chemistry Systems. The proposed labeling indicates the ADVIA Chemistry Total Bilirubin_2 reagents can be used on the ADVIA Chemistry Systems 1650, 1800, 2400, and 1200. The Total Bilirubin_2 assay is based on a chemical oxidation method, utilizing vanadate as the oxidizing agent. Total bilirubin (conjugated and unconjugated) is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both conjugated and unconjugated bilirubin are oxidized. This oxidation causes a decrease in optical density of the yellow color, which is specific to bilirubin. The decrease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.

Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems. Measurements of total bilirubin in serum and plasma are used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, such as jaundice, biliary obstruction, hepatitis and cirrhosis.

The Dri-STAT® Enzymatic Bilirubin Reagent may be used in conjunction with the SYNCHRON® Systems Bilirubin Calibrator on the family of SYNCHRON® Systems. The reagent kit contains two reagent bottles that are transferred into a Beckman Coulter User-Defined Cartridge.

The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and 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.

The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

Serum bilirubin measurement is widely used as a screening test for liver functions.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.