SCK

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

产品代码

SCK

器械名称

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

FDA 分类定义

Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT Rule (89 FR 37286).

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）。