DEM · Class II · 21 CFR 866.5130

FDA Product Code DEM: Alpha-1-antitrypsin, Antigen, Antiserum, Control

Leading manufacturers include Ventana Medical Systems, Inc., Kallestad Diag, A Div. of Erbamont, Inc. and The Binding Site, Ltd..

30
Total
30
Cleared
93d
Avg days
1976
Since
30 devices
25–30 of 30
Cleared Nov 16, 1976
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
K760916
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 19d
Cleared Aug 11, 1976
TEST, STREP, LATEX SLIDE
K760034
Gamma Biologicals, Inc.
Microbiology · 58d