NHG · Class II · 21 CFR 862.1205

FDA Product Code NHG: Enzyme Immunoassay, Cortisol, Salivary

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.

Leading manufacturers include Roche Diagnostics Corp. and Roche Diagnostics.

7
Total
7
Cleared
216d
Avg days
2001
Since

FDA 510(k) Cleared Enzyme Immunoassay, Cortisol, Salivary Devices (Product Code NHG)

7 devices
1–7 of 7
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788
Roche Diagnostics
Chemistry · 197d
Cleared Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K043175
Roche Diagnostics Corp.
Chemistry · 8d

About Product Code NHG - Regulatory Context