FDA Product Code PCG: 21-hydroxylase Antibody (21-ohab)
For Semi-quantitative Determination Of Antibodies To Steroid 21-hydroxylase (21-oh) In Human Serum. The Assay May Be Useful As An Aid In The Diagnosis Of Autoimmune Adrenal Disease, Whether Expressed As Autoimmune Addison's Disease (isolated) Or Addison's Disease As Part Of More Complex Autoimmune Polyglandular Syndrome (aps), Type I Or Ii. The Assay Result Is To Be Used In Conjunction With Other Clinical And Laboratory Findings And Is Not A Substitute For Functional Testing Required To Diagnose Adrenal Insufficiency.
Leading manufacturers include Kronus Market Development Associates, Inc. and Kronus, Inc..
2
Total
2
Cleared
260d
Avg days
2012
Since
FDA 510(k) Cleared 21-hydroxylase Antibody (21-ohab) Devices (Product Code PCG)
2 devices
Cleared
Nov 23, 2018
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
Kronus, Inc.
Immunology
261d
Cleared
Dec 20, 2012
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
Kronus Market Development Associates, Inc.
Immunology
258d