FDA Product Code DGC: Ige, Antigen, Antiserum, Control
Leading manufacturers include Diagnostic Products Corp., Boehringer Mannheim Corp. and 3M Company.
114
Total
114
Cleared
65d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Ige, Antigen, Antiserum, Control Devices (Product Code DGC)
114 devices
Cleared
May 31, 2024
Kenota 1 Total IgE
Kenota, Inc.
Immunology
403d
Cleared
Feb 21, 2023
Quantia IgE
Biokit, S.A.
Immunology
421d
Cleared
Mar 23, 2022
Total Immunoglobulin E (IgE)
Beckman Coulter, Inc.
Immunology
61d
Cleared
Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
Siemens Healthcare Diagnostics, Inc.
Immunology
29d
Cleared
Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
Dade Behring, Inc.
Immunology
94d
Cleared
Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
Beckman Coulter, Inc.
Immunology
66d
Cleared
Jul 07, 1999
N LATEX IGE MONO REAGENT
Dade Behring, Inc.
Immunology
43d
Cleared
Nov 12, 1998
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
Boehringer Mannheim Corp.
Immunology
62d
Cleared
Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
Roche Diagnostic Systems, Inc.
Immunology
164d
Cleared
Feb 21, 1990
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
3M Company
Immunology
43d
Cleared
Feb 21, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
3M Company
Immunology
35d
Cleared
Nov 13, 1989
ABBOTT IMX IGE
Abbott Laboratories
Immunology
34d
Cleared
Sep 28, 1989
MILENIA(TM) TOTAL IGE (MKIE1,5)
Diagnostic Products Corp.
Immunology
51d
Cleared
Jun 02, 1989
ALATOP (TM) CATALOG # AKAL1
Diagnostic Products Corp.
Immunology
60d
Cleared
Sep 10, 1987
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
Diagnostic Products Corp.
Immunology
48d
Cleared
Oct 29, 1986
ENZYMUN-TEST(R) IGE
Boehringer Mannheim Corp.
Immunology
29d
Cleared
Apr 11, 1986
TOTAL IGE-IRMA RIA KIT
Diagnostic Products Corp.
Immunology
95d
Cleared
Apr 07, 1986
EIA MONOCLONAL TOTAL IGE KIT
Diagnostic Products Corp.
Immunology
91d
Cleared
Aug 28, 1985
THE DPC MONOCLONAL EIA TOTAL IGE KIT
Diagnostic Products Corp.
Immunology
50d
Cleared
Oct 14, 1983
ABBOTT IGE EIA
Abbott Laboratories
Chemistry
88d
About Product Code DGC - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code DGC since 1977, with 114 receiving FDA clearance (average review time: 65 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.