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.