QYD

Adalimumab Assay

Product code

QYD

Device name

Adalimumab Assay

Device class

Class 2

21 CFR

21 CFR 862.3115

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-29.