# Enzyme Immunoassay, Cortisol, Salivary
> **Product code: NHG** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1205
## Classification
- **FDA Product Code:** NHG
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1205
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NHG)
---
*AI Analytics · CC0 1.0*