NST

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

产品代码

NST

器械名称

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.5660

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERFERES WITH THE BINDING OF ACETYLCHOLINE, A NEURAL TRANSMITTER AT THE JUNCTION OF NERVES WITH MUSCLES. AUTOANTIBODY CAN ALSO BIND TO OTHER PORTIONS OF THE ACETYLCHOLINE RECEPTOR WITHOUT INTERFERING WITH ACETYLCHOLINE BINDING. PRESENCE OF AUTOANTIBODY ALONG WITH CLINICAL SIGNS AND SYMPTOMS ARE USUALLY HIGHLY SUGGESTIVE OF MYASTHENIA GRAVIS. ACETYLCHOLINE RECEPTOR AUTOANTIBODY CAN ALSO OCCUR IN THE PRESENCE OF AUTOANTIBODIES TO OTHER BODY SUBSTANCES.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。