DGC

Product Code: DGC


Products Classified as DGC

2983Ige, Antigen, Antiserum, ControlImmunoglobulins A, G, M, D, And E Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2983Ige, Antigen, Antiserum, ControlImmunoglobulins A, G, M, D, And E Immunological Test System.

FDA Consensus Standards

Ige, Antigen, Antiserum, Control [35710]21 CFR §866.5510 🔎

Pre-market Notifications for DGC

K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.
K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics Inc.
K161899ImmunoCAP 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 CuPHADIA AB
K133404IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMHPHADIA AB
K063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDADE BEHRING, INC.
K050493QUANTIA IGEBIOKIT S.A.
K042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CKAMIYA BIOMEDICAL CO.
K034057LACRYTESTADIATEC SA
K032251IMMUNETECH TOTAL IGE SYSTEMIMMUNETECH CORPORATION
K024210IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATORBECKMAN COULTER, INC.
K010855RANDOX IGERANDOX LABORATORIES, LTD.
K002560SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KITTHE BINDING SITE, LTD.
K992528BIOCHECK IGE ELISA, MODEL BC-1035BIOCHECK, INC.
K991945PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01PHARMACIA & UPJOHN CO.
K991787N LATEX IGE MONO REAGENTDADE BEHRING, INC.

Global Unique Device Identification Database

00380740054243IGE, ANTIGEN, ANTISERUM, CONTROL
00630414982410IGE, ANTIGEN, ANTISERUM, CONTROL
00630414982403IGE, ANTIGEN, ANTISERUM, CONTROL
00630414962351IGE, ANTIGEN, ANTISERUM, CONTROL
00630414599397IGE, ANTIGEN, ANTISERUM, CONTROL
00630414599380IGE, ANTIGEN, ANTISERUM, CONTROL
00630414599373IGE, ANTIGEN, ANTISERUM, CONTROL
00630414177489IGE, ANTIGEN, ANTISERUM, CONTROL
00630414177472IGE, ANTIGEN, ANTISERUM, CONTROL
00630414175331IGE, ANTIGEN, ANTISERUM, CONTROL
00813382010402IGE, ANTIGEN, ANTISERUM, CONTROL
00813382010358IGE, ANTIGEN, ANTISERUM, CONTROL
00813382010280IGE, ANTIGEN, ANTISERUM, CONTROL
00813382010099IGE, ANTIGEN, ANTISERUM, CONTROL
00813382010082IGE, ANTIGEN, ANTISERUM, CONTROL

Maude Adverse Events

VERSACELL X3 SAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2018-06-21
VERSACELL SAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-04-22
VERSACELL SAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-04-07
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2016-01-25
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2016-01-08
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2015-06-25
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2015-02-20
VERSACELL SAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2014-05-08
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2013-02-14
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-07-21
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-07-14
IMMULITE 2000 TOXOPLASMA IGGSIEMENS HEALTHCARE DIAGNOSTICS2011-05-03
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-04-11
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-04-06
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-02-17
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-02-14
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-02-04
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.2011-02-02
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-01-28
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.2011-01-17
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2011-01-13
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2011-01-05
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS, INC.2010-12-17
IMMULITE 2000 TOXOPLASMA IGGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.2010-12-16
IMMULITE 2000 TOXOPLASMA IGGSIEMENS HEALTHCARE DIAGNOSTICS INC.2010-11-23
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS, INC.2010-11-19
IMMULITE 2000 TOXOPLASMA IGGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2010-11-12
IMMULITE 2000 TOXOPLASMA IGGSIEMENS HEALTHCARE DIAGNOSTICS INC2010-11-12
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-10-28
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-10-12
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-04-09
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-03-19
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-02-11
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2010-02-05
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2009-10-19
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2009-06-08
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2009-05-15
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2009-03-27
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS2009-02-13
IMMULITE 2000 RUBELLA IGGSIEMENS HEALTHCARE DIAGNOSTICS INC.2008-11-24
IMMULITE 2000 THIRD GEN TSHSIEMENS HEALTHCARE DIAGNOSTICS INC.2008-11-24
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.