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Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.

The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration. The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations. The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.