DeviceClearance

Product code QYD— Clinical Toxicology

Procise ADL

Classification name
Adalimumab Assay
Device class
Class 2
Regulation
21 CFR 862.3115
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QYD under 21 CFR 862.3115, via openFDA

Market context for product code QYD

FDA has cleared 1 device under product code QYD, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QYD

Recent clearances under product code QYD

Data sourced from openFDA. This site is unofficial and independent of the FDA.