FDA Product Code LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Syphilis serology is a core component of STI screening. FDA product code LIP covers enzyme-linked immunosorbent assay systems for Treponema pallidum antibody detection.
These treponemal immunoassays detect IgG and IgM antibodies specific to Treponema pallidum antigens for the screening and diagnosis of syphilis. Modern EIA-based treponemal tests are increasingly used as first-line syphilis screening tests.
LIP devices are Class II medical devices, regulated under 21 CFR 866.3830 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Diagnostics, Beckman Coulter, Inc. and Ortho-Clinical Diagnostics.
List of Enzyme Linked Immunoabsorption Assay, Treponema Pallidum devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Linked Immunoabsorption Assay, Treponema Pallidum devices (product code LIP). 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 →