产品英文名称：PYROGENT™ Gel Clot LAL Single Test Vials

产品中文名称：PYROGENT™鲎变形细胞裂解物(LAL)凝胶法单一检测试剂盒

PYROGENT™ LAL 凝胶法单一检测试剂盒 产品介绍：

PYROGENT™ Gel Clot LAL Single Test Vial kit 由25个无热原检测安瓿小瓶组成，检测小瓶中含有冻干的鲎变形细胞裂解物（LAL）。LAL检测是一种对于存在的革兰氏阴性细菌(G^–)内毒素的定性检测。LAL内含能被微量G^–细菌内毒素激活的凝固酶原（Proclotting enzyme）和凝固蛋白原（Coagulogen），适宜条件下细菌内毒素激活鲎试剂中的凝固酶原，发生凝集反应形成凝胶，如果没有内毒素存在则不形成凝胶。检测方法简单，只要在安瓿瓶中添加250µl样品或对照品，适当温育一段时间（37℃，1小时）就能得到检测结果(具体检测方法参照说明书)。无需频繁移液，适合微量样品检测。The PYROGENT™ Gel Clot LAL Single Test Vial kit 灵敏度为0.125 EU/ml。每个试剂盒包含25个检测小瓶。试剂盒不含有对照用标准内毒素。产品主要应用于人或动物注射药物终产品体外内毒素检测，生物制品和医疗用具等的内毒素检测。产品不能用于临床样品内毒素检测，也不能辅助人类疾病诊断。

注意事项：

¡ 本品为体外诊断试剂，严禁用于人体内毒素检测

¡ 本品用于药品的G-细菌内毒素检测时，应遵循USP药典细菌内毒素检测法的规定

¡ 使用安瓿包装的鲎试剂在开启时，应防止玻璃屑落入瓶内，开启安瓿后应马上使用

PYROGENT™ Gel Clot LAL Single Test Vials英文介绍：

This product is intended as an In Vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. This product is not intended for the detection of endotoxin in clinical samples or as an aid in the diagnosis of human disease. The Limulus Amebocyte Lysate (LAL) test is a qualitative test for Gram-negative bacterial endotoxin. Limulus Amebocyte Lysate as supplied is to be reconstituted with the solution being tested. After incubation, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur.

In December, 1987, the United States Food and Drug Administration (FDA) published the “Guideline on Validation of the Limulus Amebocyte Lysate Test As an End-product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices”10. This guideline outlines those procedures which the FDA considers necessary for: 1) establishing endotoxin limits for pharmaceuticals and medical devices, 2) validating the use of LAL as an endproduct endotoxin test, and 3) developing a routine testing protocol.

订购信息：

N183-06(Cat#) PYROGENT™ Gel Clot LAL 80tests(size) 0.06EU/ml(Sensitivity)

N186 Endotoxin(E.coli) for Gel Clot Assays 5vials(size)

S50-642 Tris Buffer 30ml vial(size) 50mM Solution(Comments) 2-8℃(storage)

W50-100LAL Reagent Water 100ml <0.005EU/ml 15-30℃(storage)