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
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
1–24 of 114
Cleared May 31, 2024
Kenota 1 Total IgE
K231151
Kenota, Inc.
Immunology · 403d
Cleared Feb 21, 2023
Quantia IgE
K214068
Biokit, S.A.
Immunology · 421d
Cleared Mar 23, 2022
Total Immunoglobulin E (IgE)
K220178
Beckman Coulter, Inc.
Immunology · 61d
Cleared Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
K193493
Siemens Healthcare Diagnostics, Inc.
Immunology · 29d
Cleared Jul 28, 2016
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K161899
Phadia AB
Immunology · 17d
Cleared Feb 24, 2014
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K133404
Phadia AB
Immunology · 110d
Cleared Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425
Dade Behring, Inc.
Immunology · 94d
Cleared Aug 16, 2005
QUANTIA IGE
K050493
Biokit, S.A.
Immunology · 169d
Cleared Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241
Kamiya Biomedical Co.
Immunology · 113d
Cleared Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210
Beckman Coulter, Inc.
Immunology · 66d
Cleared May 15, 2001
RANDOX IGE
K010855
Randox Laboratories, Ltd.
Immunology · 54d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560
The Binding Site, Ltd.
Immunology · 70d
Cleared Sep 21, 1999
BIOCHECK IGE ELISA, MODEL BC-1035
K992528
Biocheck, Inc.
Immunology · 55d
Cleared Aug 09, 1999
TOUCH TEAR IGE MICROASSAY KIT
K991316
Touch Scientific, Inc.
Immunology · 112d
Cleared Jul 28, 1999
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
K991945
Pharmacia & Upjohn Co.
Immunology · 49d
Cleared Jul 07, 1999
N LATEX IGE MONO REAGENT
K991787
Dade Behring, Inc.
Immunology · 43d
Cleared Nov 12, 1998
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185
Boehringer Mannheim Corp.
Immunology · 62d
Cleared Oct 03, 1997
AIA-PACK IGE II ASSAY
K972697
Tosoh Medics, Inc.
Immunology · 77d
Cleared Apr 23, 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152
Pharmacia, Inc.
Immunology · 189d
Cleared May 17, 1994
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183
Hycor Biomedical, Inc.
Immunology · 125d
Cleared Apr 21, 1994
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594
Ciba Corning Diagnostics Corp.
Immunology · 209d
Cleared Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
K930890
Roche Diagnostic Systems, Inc.
Immunology · 164d
Cleared Aug 05, 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180
Inova Diagnostics, Inc.
Immunology · 36d
Cleared Jun 09, 1993
ACCESS(R) TOTAL IGE ASSAY
K930984
Bio-Rad Laboratories, Inc.
Immunology · 104d

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.