FDA Product Code DHA: System, Test, Human Chorionic Gonadotropin
Under FDA product code DHA, human chorionic gonadotropin test systems are cleared for the detection of pregnancy and the monitoring of hCG-producing conditions.
These immunoassays detect hCG — the hormone produced by the placenta after implantation — in urine or serum. They are used for pregnancy confirmation, ectopic pregnancy diagnosis, monitoring of gestational trophoblastic disease, and tumor marker surveillance.
DHA devices are Class II medical devices, regulated under 21 CFR 862.1155 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Abbott Laboratories, Siemens Healthcare Diagnostics, Inc. and Roche Diagnostics.
List of System, Test, Human Chorionic Gonadotropin devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Human Chorionic Gonadotropin devices (product code DHA). 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 Chemistry FDA review panel. Browse all Chemistry devices →