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, Dade Behring, Inc. and Germaine Laboratories, Inc..