DGC · Class II · 21 CFR 866.5510

FDA Product Code DGC: Ige, Antigen, Antiserum, Control

Leading manufacturers include Pharmacia, Inc., Ventrex Laboratories, Inc. and Kallestad Laboratories, Inc..

114
Total
114
Cleared
65d
Avg days
1977
Since
114 devices
73–96 of 114
Cleared May 05, 1982
VENTRE/SPEC IGE CONTROLS
K820897
Ventrex Laboratories, Inc.
Immunology · 36d
Cleared Apr 21, 1982
VENTREX 125I ANTI-IGE ALLERGY ISOTOPE
K820896
Ventrex Laboratories, Inc.
Immunology · 22d
Cleared Dec 31, 1981
PHADEBAS/PHADEZYM IGE REAGENTS
K813189
Pharmacia, Inc.
Immunology · 45d
Cleared Jul 10, 1981
VENTRE/SEP IGE RIA TEST SET
K811559
Ventrex Laboratories, Inc.
Chemistry · 38d
Cleared Jun 24, 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545
Kallestad Laboratories, Inc.
Chemistry · 23d
Cleared May 29, 1981
TAN DEM* - IGE KIT
K802913
Hybritech, Inc.
Chemistry · 192d
Cleared Mar 20, 1981
PHADEZYM IGE PRIST TEST
K810507
Pharmacia, Inc.
Immunology · 24d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Jun 06, 1978
LAS-R HUMAN IGE TEST
K780753
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 29d
Cleared Jul 15, 1977
RID PLATES & INTENSI. FOR HUMAN IGE ETC
K771238
G.D. Searle and Co.
Immunology · 4d