Immunology and Microbiology Devices

United States · Last verified: 2026-09-08

Number

21 CFR 866

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

免疫学与微生物学器械分类目录：涵盖诊断器械、微生物学器械、血清学试剂、免疫实验室设备与试剂、免疫检验系统及肿瘤相关抗原检验系统，共 261 个条文。

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