Hematology and Pathology Devices

United States · Last verified: 2026-09-08

Number

21 CFR 864

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

血液学与病理学器械分类目录：涵盖生物染色剂、细胞与组织培养产品、病理仪器与附件、标本制备试剂、自动/半自动及手工血液学器械和试剂盒，共 126 个条文。

Source: U.S. Food and Drug Administration (public domain)