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
25–48 of 114
Cleared Aug 05, 1992
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
K922047
Medix Biotech, Inc.
Immunology · 96d
Cleared Apr 08, 1992
ACS TOTAL IGE IMMUNOASSAY
K920372
Ciba Corning Diagnostics Corp.
Immunology · 71d
Cleared Jul 25, 1991
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800
Bio-Rad Laboratories, Inc.
Immunology · 30d
Cleared Apr 24, 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631
Pharmacia, Inc.
Immunology · 13d
Cleared Mar 12, 1991
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082
Quidel Corp.
Immunology · 63d
Cleared Feb 21, 1991
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
K905612
Ventrex Laboratories, Inc.
Immunology · 69d
Cleared Oct 15, 1990
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738
Quidel Corp.
Immunology · 60d
Cleared Feb 21, 1990
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
K900108
3M Company
Immunology · 43d
Cleared Feb 21, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
K900244
3M Company
Immunology · 35d
Cleared Nov 13, 1989
ABBOTT IMX IGE
K895914
Abbott Laboratories
Immunology · 34d
Cleared Sep 28, 1989
MILENIA(TM) TOTAL IGE (MKIE1,5)
K895004
Diagnostic Products Corp.
Immunology · 51d
Cleared Jul 14, 1989
PHARMACIA CAP SYSTEM IGE RIA AND FEIA
K893951
Pharmacia, Inc.
Immunology · 43d
Cleared Jun 02, 1989
ALATOP (TM) CATALOG # AKAL1
K892197
Diagnostic Products Corp.
Immunology · 60d
Cleared Mar 27, 1989
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K890530
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Nov 10, 1988
DELFIA (TM) HIGE KIT
K884545
Pharmacia, Inc.
Immunology · 10d
Cleared Aug 08, 1988
PHARMACIA IGE RIA ULTRA
K882625
Pharmacia, Inc.
Chemistry · 42d
Cleared Aug 04, 1988
PHARMACIA IGE EIA ULTRA
K882626
Pharmacia, Inc.
Immunology · 38d
Cleared Jun 10, 1988
PHARMACIA IGE RIACT
K881892
Pharmacia, Inc.
Immunology · 37d
Cleared Feb 17, 1988
RRT TOTAL IGE TEST KIT
K874541
Incstar Corp.
Immunology · 106d
Cleared Nov 25, 1987
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406
Medix Biotech, Inc.
Immunology · 28d
Cleared Sep 10, 1987
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
K872913
Diagnostic Products Corp.
Immunology · 48d
Cleared Dec 03, 1986
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142
United Biotech, Inc.
Immunology · 42d
Cleared Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858
Hybritech, Inc.
Immunology · 31d
Cleared Oct 29, 1986
ENZYMUN-TEST(R) IGE
K863822
Boehringer Mannheim Corp.
Immunology · 29d