FDA Product Code LOL: Hepatitis A Test (antibody And Igm Antibody)
Under FDA product code LOL, hepatitis A antibody and IgM antibody tests are cleared for the serological diagnosis of hepatitis A virus infection.
These immunoassays detect total anti-HAV antibody for immunity assessment and IgM anti-HAV for acute infection diagnosis. The presence of IgM antibody indicates recent HAV infection, distinguishing acute from past infection in patients with acute hepatitis.
LOL devices are Class II medical devices, regulated under 21 CFR 866.3310 and reviewed by the FDA Microbiology panel.
Leading manufacturers include DiaSorin, Inc., Beckman Coulter, Inc. and Abbott Laboratories.
List of Hepatitis A Test (antibody And Igm Antibody) devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Hepatitis A Test (antibody And Igm Antibody) devices (product code LOL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →