NHG

Enzyme Immunoassay, Cortisol, Salivary

Product code

NHG

Device name

Enzyme Immunoassay, Cortisol, Salivary

Device class

Class 2

21 CFR

21 CFR 862.1205

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

7 (all years; only the last 3 years are listed here)

FDA classification definition

The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.

Definition text from the FDA device classification database (U.S. federal government work, public domain).