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 Salimetrics, LLC, Roche Diagnostics and Pantex, Div. Bio-Analysis, Inc..
7
Total
7
Cleared
216d
Avg days
2001
Since
FDA 510(k) Cleared Enzyme Immunoassay, Cortisol, Salivary Devices (Product Code NHG)
7 devices
Cleared
Nov 25, 2015
Cortisol Saliva Luminescence Immunoassay
Ibl International GmbH
Chemistry
268d
Cleared
May 08, 2012
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
Pantex, Div. Bio-Analysis, Inc.
Chemistry
587d
Cleared
Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
Roche Diagnostics
Chemistry
197d
Cleared
Dec 07, 2005
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
Drg Intl., Inc.
Chemistry
162d
Cleared
Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
Roche Diagnostics Corp.
Chemistry
8d
Cleared
Jun 10, 2003
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
Salimetrics, LLC
Chemistry
60d
Cleared
Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
Salimetrics, LLC
Chemistry
230d