In Vitro Diagnostic Products for Human Use

United States · Last verified: 2026-09-08

Number

21 CFR 809

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

人用体外诊断产品（IVD）：IVD 定义、标签要求（含仅供研究用 RUO、仅供试验用 IUO 标示）以及对制造商和生产者的要求。

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