Lipogen, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Lipogen, Inc. makes
Lipogen, Inc. manufactures in vitro diagnostic tests for detecting autoantibodies, including assays for systemic lupus erythematosus (SLE) markers such as anti-Smith (SM), anti-SS-B/La, anti-SS-A/Ro, and anti-dsDNA antibodies. Their portfolio includes antibody test kits and immunoassays for screening and profiling rheumatoid factor (RF) and antinuclear antibodies (ANA), as well as specialized assays for RNP and NDNA antibodies.
The company’s diagnostic tests are classified under FDA’s Class I and Class II categories, with regulatory submissions supported through 510(k) clearances. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Lipogen, Inc. have in the registry?
The registry currently lists 15 devices for Lipogen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lipogen, Inc.'s devices?
Among its 15 most recently registered devices, Lipogen, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Lipogen, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Lipogen, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lipogen, Inc. in the registry?
The most recently registered devices listed for Lipogen, Inc. include SM ANTIBODY TEST KIT, ACCESS R-CLONE ANA PROFILE ASSAY, LA ANTIBODY TEST KIT and RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES.