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Endotoxin and Rapid Microbiological Products
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FDA-Licensed Kinetic LAL Reagents Limulus Amebocyte Lysate (LAL) is the most sensitive and specific assay available to screen injectable drugs, biologics, medical devices, and raw materials for the presence of endotoxin. Our optimized formulations provide increased sensitivity, greater linearity, and superior interference resistance. Our LAL Reagents are licensed by the Food and Drug Administration for product release. Kinetic Turbidimetric Reagent Kinetic Turbidimetric Analysis (KTA) reagents yield quantitative endotoxin values when used with a multi-tube or microplate reader with endotoxin measuring software.
Kinetic Chromogenic Reagents Endochrome-K is a kinetic chromogenic reagent that tests for quantitative endotoxin values. A colorless substrate and LAL are co-lyophilized into a single, stable reagent. The unique stability of our reconstituted LAL allows for extended bench time and reuse (when stored at -20°C). Kit format and bulk packaging are available. LAL Proficiency Test Program The Proficiency Test Program (PTP) is a quarterly audit of LAL analysts, which is useful for ensuring internal quality assurance, identifying trends and possible training needs, as well as verifying method and report validation. Please contact us for more information.
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LAL Proficiency Test Program (PTP) White Paper: LAL Interference Screening White Paper: Validation of Bacterial Endotoxin Test Methods What's New
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