Bacterial Endotoxin LAL Gel-Clot LAL Kinetic Cytotoxicity Biocompatibility Studies Blood Compatibility

The FDA has recognized the LAL Test Method as an official end product Release Test for Bacterial Endotoxins. Transfusion and Infusion Assemblies and similar Medical Devices are tested to comply with regulatory and compendium requirements. LAL testing follows the procedure described in the U.S. Pharmacopeia and the FDA Guideline of 1987. Traditional, gel-clot methods and Photometric determinations are available. APPLICABLE TEST PROFILES LAL Medical Device Extract - Gel Clot w/CSE - FDA Method LAL Gel Clot w/RSE - USP Method LAL Inhibition/Enhancement FDA Method Turbidimetric LAL Method Chromogenic Method