ORH

Lamotrigine Assay

Product code

ORH

Device name

Lamotrigine Assay

Device class

Class 2

21 CFR

21 CFR 862.3350

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.

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