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The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitation of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.

Lp(a) Ultra assay is composed by 2 ready to use liquid reagents (Reagent 1and Reagent 2) that are supplied in the following configuration: Reagent 1 fill volume 18 mL in a 20 mL wedge and Reagent 2 fill volume 9 mL in a 20 mL wedge, 1 wedge of each/kit. The kit contains one plastic (HDPE) vial of Reagent 1 and one plastic (HDPE) vial of Reagent 2, which allows the customer to perform 86 tests (on AU680 automatic analyzer).

The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The assay is intended for professional use only. For In Vitro Diagnostic use only.

Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrents, in patients with stable coronary disease or acute coronary syndrome.

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The ACE Calibrator is a device intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensing enzyme (ACE) assay in human serum or plasma. The product is for in vitro diagnostic use only.

The ACE Calibrator is a single level, single analyte serum based calibrator. It consists of a lyophilized preparation of human serum containing angiotensin converting enzyme (porcine source), in a buffered human serum base with added preservatives and stabilizers. The kit consists of six vials, containing 1 mL per vial. Once reconstituted, the calibrator is stable for 7 days when stored capped at 2-8°C.

The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum. Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.

Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.

The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. Measurement of type of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus, in conjunction with other clinical and laboratory findings.

The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. The determination of Kappa light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Kappa light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

Clinical Chemistry - The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid 1 - Antitrypsin, Glycoprotein, Alpha Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma. Sentinel Plasmaproteins Cal 3x must only be used for the calibration of plasmaprotein tests with the immunoturbidimetric methods.

The Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in a human serum matrix. This material, when stored as directed, is stable until the date printed on the label. Calibrator traceability was stated as certificated to CRM 470 (Certified Reference Material), renamed ERM-DA 470 (European Reference Materials).

The MULTIGENT Creatinine (Enzymatic) assay is a device intended to measure creatinine levels in human serum, plasma, and urine using the ARCHITECT c8000 System and the AEROSET System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a component of various calculations for determination or estimation of creatinine clearance, glomerular filtration rate (GFR) or estimated GFR (eGFR).

MULTIGENT Creatinine (Enzymatic) Assay is an in vitro diagnostic device for the quantitative determination of creatinine in human serum, plasma, or urine. Creatinine in the sample is hydrolyzed by creatininase to creatine. Creatine is in turn hydrolyzed by creatinase to sarcosine and urea. Sarcosine from this reaction is oxidized by sarcosine oxidase to glycine and formaldehyde, with the concomitant production of hydrogen peroxide. The H2O2 reacts with 4-aminoantipyrine and ESPMT (N-Ethyl-N-sulfopropyl-m-toluidine) in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the creatinine concentration in the sample.