Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Ige, Antigen, Antiserum, Control

FDA product code DGC · 113 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5510
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-15 – 2024-05-31

DGC 2024-05-31

Kenota 1 Total IgE; Kenota 1 (instrument)

Applicant Kenota, Inc.

K number K231151

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DGC 2023-02-21

Quantia IgE

Applicant Biokit, S.A.

K number K214068

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DGC 2022-03-23

Total Immunoglobulin E (IgE)

Applicant Beckman Coulter, Inc.

K number K220178

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DGC 2020-01-15

ADVIA Centaur Total IgE (tIgE)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K193493

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DGC 2016-07-28

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

Applicant Phadia AB

K number K161899

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DGC 2007-02-15

DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH

Applicant Dade Behring, Inc.

K number K063425

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DGC 2005-08-16

QUANTIA IGE

Applicant Biokit, S.A.

K number K050493

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DGC 2004-12-10

K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

Applicant Kamiya Biomedical Co.

K number K042241

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DGC 2004-03-09

LACRYTEST

Applicant Adiatec SA

K number K034057

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DGC 2003-12-19

IMMUNETECH TOTAL IGE SYSTEM

Applicant Immunetech Corporation

K number K032251

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DGC 2003-02-24

IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K024210

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DGC 2001-05-15

RANDOX IGE

Applicant Randox Laboratories, Ltd.

K number K010855

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DGC 2000-10-26

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

Applicant The Binding Site, Ltd.

K number K002560

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DGC 1999-09-21

BIOCHECK IGE ELISA, MODEL BC-1035

Applicant Biocheck, Inc.

K number K992528

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DGC 1999-08-09

TOUCH TEAR IGE MICROASSAY KIT

Applicant Touch Scientific, Inc.

K number K991316

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DGC 1999-07-28

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

Applicant Pharmacia & Upjohn Co.

K number K991945

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DGC 1999-07-07

N LATEX IGE MONO REAGENT

Applicant Dade Behring, Inc.

K number K991787

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DGC 1998-11-12

BOEHRINGER MANNHEIM TINA-QUANT IGE TEST

Applicant Boehringer Mannheim Corp.

K number K983185

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DGC 1997-10-03

AIA-PACK IGE II ASSAY

Applicant Tosoh Medics, Inc.

K number K972697

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DGC 1997-04-23

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH

Applicant Pharmacia, Inc.

K number K964152

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DGC 1994-05-17

HY-TEC TOTAL IGE ENZYME IMMUNOASSAY

Applicant Hycor Biomedical, Inc.

K number K940183

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DGC 1994-04-21

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

Applicant Ciba Corning Diagnostics Corp.

K number K934594

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DGC 1993-08-05

QUANTA LITE MITOCHONDRIA M2 ELISA

Applicant Inova Diagnostics, Inc.

K number K933180

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DGC 1993-08-05

COBAS(R) CORE IGE TOTAL EIA

Applicant Roche Diagnostic Systems, Inc.

K number K930890

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DGC 1993-06-09

ACCESS(R) TOTAL IGE ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K930984

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DGC 1992-11-25

PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION

Applicant Kabi Pharmacia, Inc.

K number K923832

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DGC 1992-08-05

IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

Applicant Medix Biotech, Inc.

K number K922047

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DGC 1992-04-08

ACS TOTAL IGE IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K920372

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DGC 1991-07-25

KALLESTEAD TOTAL IGE MICROPLATE KIT

Applicant Bio-Rad Laboratories, Inc.

K number K912800

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DGC 1991-06-21

BIOCLONE'S ELEGANCE IGE ELISA KIT

Applicant Bioclone Australia Pty , Ltd.

K number K910419

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DGC 1991-04-24

PHARMACIA SPECIFIC IGE CONTROL

Applicant Pharmacia, Inc.

K number K911631

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DGC 1991-03-12

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK

Applicant Quidel Corp.

K number K910082

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DGC 1991-02-21

VENTREX COATED TUBE IGE RADIOIMMUNOASSAY

Applicant Ventrex Laboratories, Inc.

K number K905612

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DGC 1990-10-15

QUIDEL ALLERGEN SCREEN POSITIVE CONTROL

Applicant Quidel Corp.

K number K903738

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DGC 1990-08-02

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY

Applicant London Diagnostics, Inc.

K number K903195

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DGC 1990-02-21

3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8

Applicant 3M Company

K number K900244

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DGC 1990-02-21

3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12

Applicant 3M Company

K number K900108

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DGC 1989-11-13

ABBOTT IMX IGE

Applicant Abbott Laboratories

K number K895914

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DGC 1989-09-28

MILENIA(TM) TOTAL IGE (MKIE1,5)

Applicant Diagnostic Products Corp.

K number K895004

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DGC 1989-09-21

PROGENE IGE BEAD EIA

Applicant Progene Corp.

K number K895294

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DGC 1989-07-14

PHARMACIA CAP SYSTEM IGE RIA AND FEIA

Applicant Pharmacia, Inc.

K number K893951

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DGC 1989-06-02

ALATOP (TM) CATALOG # AKAL1

Applicant Diagnostic Products Corp.

K number K892197

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DGC 1989-03-27

N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)

Applicant Behring Diagnostics, Inc.

K number K890530

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DGC 1989-03-08

FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

Applicant Alerchek, Inc.

K number K885307

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DGC 1988-11-10

DELFIA (TM) HIGE KIT

Applicant Pharmacia, Inc.

K number K884545

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DGC 1988-08-08

PHARMACIA IGE RIA ULTRA

Applicant Pharmacia, Inc.

K number K882625

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DGC 1988-08-04

PHARMACIA IGE EIA ULTRA

Applicant Pharmacia, Inc.

K number K882626

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DGC 1988-06-10

PHARMACIA IGE RIACT

Applicant Pharmacia, Inc.

K number K881892

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DGC 1988-02-17

RRT TOTAL IGE TEST KIT

Applicant Incstar Corp.

K number K874541

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DGC 1987-11-25

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064

Applicant Medix Biotech, Inc.

K number K874406

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DGC 1987-09-10

ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5

Applicant Diagnostic Products Corp.

K number K872913

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DGC 1987-08-28

ULTRASCAN IGE ASSAY KIT

Applicant Specialty Medical Industries, Inc.

K number K872968

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DGC 1986-12-03

UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE

Applicant United Biotech, Inc.

K number K864142

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DGC 1986-11-03

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--

Applicant Hybritech, Inc.

K number K863858

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DGC 1986-10-29

ENZYMUN-TEST(R) IGE

Applicant Boehringer Mannheim Corp.

K number K863822

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DGC 1986-08-06

TIMOTHY ALLERGEN DISC

Applicant Immuno Nuclear Corp.

K number K862174

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DGC 1986-07-03

AMPLIFIED ELISA IGE KIT

Applicant Allertec, Inc.

K number K862368

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DGC 1986-04-25

QUIDEL ALLERGY SCREEN

Applicant Quidel Corp.

K number K861171

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DGC 1986-04-11

TOTAL IGE-IRMA RIA KIT

Applicant Diagnostic Products Corp.

K number K860032

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DGC 1986-04-07

EIA MONOCLONAL TOTAL IGE KIT

Applicant Diagnostic Products Corp.

K number K860033

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DGC 1985-08-28

THE DPC MONOCLONAL EIA TOTAL IGE KIT

Applicant Diagnostic Products Corp.

K number K852878

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DGC 1985-08-22

IMAGE-IGE

Applicant Clinical Reference Laboratory, Inc.

K number K853025

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DGC 1985-07-10

QUANTICLONE IGE RADIOIMMUNASSAY

Applicant Kallestad Laboratories, Inc.

K number K852268

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DGC 1985-04-25

PHARMACIA IGE RIA MODIFIED

Applicant Pharmacia, Inc.

K number K851156

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DGC 1985-04-12

TOTAL HIGE ENZYME IMMUNOASSAY

Applicant Nms Pharmaceuticals, Inc.

K number K850786

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DGC 1984-11-14

AGGLUTINATION TEST FOR TOTAL IGE

Applicant Scientific Research

K number K843369

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DGC 1984-10-22

ELISA FOR TOTAL IGE

Applicant Scientific Research

K number K843710

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DGC 1984-10-01

ENCORE IGE REAGENT

Applicant Hybritech, Inc.

K number K843408

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DGC 1984-06-07

ALLERCOAT ALLERGEN DISCS

Applicant Kallestad Laboratories, Inc.

K number K842125

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DGC 1984-06-07

PHADEBAS RAST PHADEZYM RAST ALLERGEN

Applicant Pharmacia, Inc.

K number K841829

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DGC 1984-06-07

PHARMACIA IGE RIA

Applicant Pharmacia, Inc.

K number K841824

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DGC 1984-06-07

MAST LUMINESCENT ALLERGY SYS

Applicant Mast Immunosystems

K number K841642

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DGC 1984-06-01

VAST VENTREX RAST ALL

Applicant Ventrex Laboratories, Inc.

K number K841651

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DGC 1984-05-21

PHADEXACT SERUM, TOTAL IGE CONTROLS

Applicant Pharmacia, Inc.

K number K840476

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DGC 1984-04-04

SENSIBEAD EIA IGE KIT

Applicant Terumo Medical Corp.

K number K840674

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DGC 1984-03-23

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE

Applicant Pharmacia, Inc.

K number K840538

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DGC 1984-02-10

TOTAL IGE FAST TEST

Applicant Allergenetics

K number K834594

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DGC 1984-02-03

LABELED 125I ANTI-IGE

Applicant Allergenetics

K number K833419

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DGC 1984-01-04

MAST TOTAL IGE

Applicant Mast Immunosystems

K number K833969

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DGC 1983-11-25

POLYSTYRENE MICROTITER WELL IMMUNOSOR

Applicant Diagnostic Reagent Tech.

K number K832345

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DGC 1983-10-14

ABBOTT IGE EIA

Applicant Abbott Laboratories

K number K832360

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DGC 1983-09-20

ALLERGEN CONTROL INHALENT

Applicant Ventrex Laboratories, Inc.

K number K832218

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DGC 1983-06-02

VENTRE/ZYME IGE KIT

Applicant Ventrex Laboratories, Inc.

K number K831485

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DGC 1983-06-02

IGE RADIOIMMUNOASSAY KIT

Applicant American Diagnostic Corp.

K number K831377

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DGC 1983-06-02

ALLERCOAT ALLERGEN DISCS

Applicant Kallestad Laboratories, Inc.

K number K831326

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DGC 1983-05-09

IGE-QUANT DIAGNOSTIC TEST KIT

Applicant Leeco Diagnostics, Inc.

K number K831208

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DGC 1983-04-27

NEW ALLERGEN DISCS FOR USE IN VAST VENT

Applicant Ventrex Laboratories, Inc.

K number K830817

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DGC 1983-03-17

RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E

Applicant Clinetics Corp.

K number K830357

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DGC 1983-03-01

DENSITOMETRIC INHALENT PROFILE SLLER

Applicant Mast Immunosystems

K number K830164

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DGC 1983-01-14

TOTAL IGE-FAST TEST

Applicant Axonics, Inc.

K number K823494

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DGC 1983-01-12

PHADEZYM RAST ALLERGEN DISCS

Applicant Pharmacia, Inc.

K number K823842

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DGC 1983-01-12

PHADEBAS RAST ALLERGEN DISCS

Applicant Pharmacia, Inc.

K number K823841

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DGC 1982-12-28

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K823507

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DGC 1982-12-15

ALLERCOAT POSITIVE CONTROL SERUM

Applicant Kallestad Laboratories, Inc.

K number K823403

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DGC 1982-11-10

ALLERGENETICS IGE-FAST TEST

Applicant Allergenetics

K number K822341

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DGC 1982-10-22

RAST ALLERCOAT ALLERGEN DISCS

Applicant Kallestad Laboratories, Inc.

K number K822613

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DGC 1982-09-02

VAST VENTREX RAST ALLERGEN DISCS

Applicant Ventrex Laboratories, Inc.

K number K822442

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DGC 1982-08-16

TOTAL IGE DISCS

Applicant Kallestad Laboratories, Inc.

K number K822206

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DGC 1982-06-22

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

Applicant Clinical Assays, Inc.

K number K821092

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DGC 1982-06-11

VENTRE/SPEC ALLERGEN CONTROL-INHALANT

Applicant Ventrex Laboratories, Inc.

K number K820978

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