NHG
7 FDA 510(k) clearances · Product code
197 daysmedian time to decision
587 days90th percentile
7clearances measured
FDA profile
- Official device name
- Enzyme Immunoassay, Cortisol, Salivary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1205
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cortisol Saliva Luminescence Immunoassay (K150528) | Ibl International GmbH | 2015-11-25 |
| PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| ELECSYS CORTISOL TEST SYSTEM (K070788) | Roche Diagnostics | 2007-10-05 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (K051733) | Drg Intl., Inc. | 2005-12-07 |
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (K031348) | Salimetrics, LLC | 2003-06-10 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (K011323) | Salimetrics, LLC | 2001-12-17 |
Track NHG automatically
Every clearance here is in the API, with alerts when new ones post.