Atlas FDA

DGC

114 FDA 510(k) clearances · Product code

45 daysmedian time to decision
123 days90th percentile
114clearances measured

FDA profile

Official device name
Ige, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2008: 2 · 2009: 5 · 2010: 12 · 2011: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Kenota 1 Total IgE; Kenota 1 (instrument) (K231151)Kenota, Inc.2024-05-31
Quantia IgE (K214068)Biokit, S.A.2023-02-21
Total Immunoglobulin E (IgE) (K220178)Beckman Coulter, Inc.2022-03-23
ADVIA Centaur Total IgE (tIgE) (K193493)Siemens Healthcare Diagnostics, Inc.2020-01-15
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 AB2016-07-28
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404)Phadia AB2014-02-24
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH (K063425)Dade Behring, Inc.2007-02-15
QUANTIA IGE (K050493)Biokit, S.A.2005-08-16
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241)Kamiya Biomedical Co.2004-12-10
LACRYTEST (K034057)Adiatec SA2004-03-09
IMMUNETECH TOTAL IGE SYSTEM (K032251)Immunetech Corporation2003-12-19
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210)Beckman Coulter, Inc.2003-02-24
RANDOX IGE (K010855)Randox Laboratories, Ltd.2001-05-15
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT (K002560)The Binding Site, Ltd.2000-10-26
BIOCHECK IGE ELISA, MODEL BC-1035 (K992528)Biocheck, Inc.1999-09-21
TOUCH TEAR IGE MICROASSAY KIT (K991316)Touch Scientific, Inc.1999-08-09
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (K991945)Pharmacia & Upjohn Co.1999-07-28
N LATEX IGE MONO REAGENT (K991787)Dade Behring, Inc.1999-07-07
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (K983185)Boehringer Mannheim Corp.1998-11-12
AIA-PACK IGE II ASSAY (K972697)Tosoh Medics, Inc.1997-10-03
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (K964152)Pharmacia, Inc.1997-04-23
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY (K940183)Hycor Biomedical, Inc.1994-05-17
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K934594)Ciba Corning Diagnostics Corp.1994-04-21
COBAS(R) CORE IGE TOTAL EIA (K930890)Roche Diagnostic Systems, Inc.1993-08-05
QUANTA LITE MITOCHONDRIA M2 ELISA (K933180)Inova Diagnostics, Inc.1993-08-05
ACCESS(R) TOTAL IGE ASSAY (K930984)Bio-Rad Laboratories, Inc.1993-06-09
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION (K923832)Kabi Pharmacia, Inc.1992-11-25
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 (K922047)Medix Biotech, Inc.1992-08-05
ACS TOTAL IGE IMMUNOASSAY (K920372)Ciba Corning Diagnostics Corp.1992-04-08
KALLESTEAD TOTAL IGE MICROPLATE KIT (K912800)Bio-Rad Laboratories, Inc.1991-07-25
BIOCLONE'S ELEGANCE IGE ELISA KIT (K910419)Bioclone Australia Pty , Ltd.1991-06-21
PHARMACIA SPECIFIC IGE CONTROL (K911631)Pharmacia, Inc.1991-04-24
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK (K910082)Quidel Corp.1991-03-12
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (K905612)Ventrex Laboratories, Inc.1991-02-21
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL (K903738)Quidel Corp.1990-10-15
LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (K903195)London Diagnostics, Inc.1990-08-02
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 (K900108)3M Company1990-02-21
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 (K900244)3M Company1990-02-21
ABBOTT IMX IGE (K895914)Abbott Laboratories1989-11-13
MILENIA(TM) TOTAL IGE (MKIE1,5) (K895004)Diagnostic Products Corp.1989-09-28
PROGENE IGE BEAD EIA (K895294)Progene Corp.1989-09-21
PHARMACIA CAP SYSTEM IGE RIA AND FEIA (K893951)Pharmacia, Inc.1989-07-14
ALATOP (TM) CATALOG # AKAL1 (K892197)Diagnostic Products Corp.1989-06-02
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) (K890530)Behring Diagnostics, Inc.1989-03-27
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY (K885307)Alerchek, Inc.1989-03-08
DELFIA (TM) HIGE KIT (K884545)Pharmacia, Inc.1988-11-10
PHARMACIA IGE RIA ULTRA (K882625)Pharmacia, Inc.1988-08-08
PHARMACIA IGE EIA ULTRA (K882626)Pharmacia, Inc.1988-08-04
PHARMACIA IGE RIACT (K881892)Pharmacia, Inc.1988-06-10
RRT TOTAL IGE TEST KIT (K874541)Incstar Corp.1988-02-17
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 (K874406)Medix Biotech, Inc.1987-11-25
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 (K872913)Diagnostic Products Corp.1987-09-10
ULTRASCAN IGE ASSAY KIT (K872968)Specialty Medical Industries, Inc.1987-08-28
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE (K864142)United Biotech, Inc.1986-12-03
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- (K863858)Hybritech, Inc.1986-11-03
ENZYMUN-TEST(R) IGE (K863822)Boehringer Mannheim Corp.1986-10-29
TIMOTHY ALLERGEN DISC (K862174)Immuno Nuclear Corp.1986-08-06
AMPLIFIED ELISA IGE KIT (K862368)Allertec, Inc.1986-07-03
QUIDEL ALLERGY SCREEN (K861171)Quidel Corp.1986-04-25
TOTAL IGE-IRMA RIA KIT (K860032)Diagnostic Products Corp.1986-04-11
EIA MONOCLONAL TOTAL IGE KIT (K860033)Diagnostic Products Corp.1986-04-07
THE DPC MONOCLONAL EIA TOTAL IGE KIT (K852878)Diagnostic Products Corp.1985-08-28
IMAGE-IGE (K853025)Clinical Reference Laboratory, Inc.1985-08-22
QUANTICLONE IGE RADIOIMMUNASSAY (K852268)Kallestad Laboratories, Inc.1985-07-10
PHARMACIA IGE RIA MODIFIED (K851156)Pharmacia, Inc.1985-04-25
TOTAL HIGE ENZYME IMMUNOASSAY (K850786)Nms Pharmaceuticals, Inc.1985-04-12
AGGLUTINATION TEST FOR TOTAL IGE (K843369)Scientific Research1984-11-14
ELISA FOR TOTAL IGE (K843710)Scientific Research1984-10-22
ENCORE IGE REAGENT (K843408)Hybritech, Inc.1984-10-01
ALLERCOAT ALLERGEN DISCS (K842125)Kallestad Laboratories, Inc.1984-06-07
PHARMACIA IGE RIA (K841824)Pharmacia, Inc.1984-06-07
PHADEBAS RAST PHADEZYM RAST ALLERGEN (K841829)Pharmacia, Inc.1984-06-07
MAST LUMINESCENT ALLERGY SYS (K841642)Mast Immunosystems1984-06-07
VAST VENTREX RAST ALL (K841651)Ventrex Laboratories, Inc.1984-06-01
PHADEXACT SERUM, TOTAL IGE CONTROLS (K840476)Pharmacia, Inc.1984-05-21
SENSIBEAD EIA IGE KIT (K840674)Terumo Medical Corp.1984-04-04
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE (K840538)Pharmacia, Inc.1984-03-23
TOTAL IGE FAST TEST (K834594)Allergenetics1984-02-10
LABELED 125I ANTI-IGE (K833419)Allergenetics1984-02-03
MAST TOTAL IGE (K833969)Mast Immunosystems1984-01-04
POLYSTYRENE MICROTITER WELL IMMUNOSOR (K832345)Diagnostic Reagent Tech.1983-11-25
ABBOTT IGE EIA (K832360)Abbott Laboratories1983-10-14
ALLERGEN CONTROL INHALENT (K832218)Ventrex Laboratories, Inc.1983-09-20
VENTRE/ZYME IGE KIT (K831485)Ventrex Laboratories, Inc.1983-06-02
ALLERCOAT ALLERGEN DISCS (K831326)Kallestad Laboratories, Inc.1983-06-02
IGE RADIOIMMUNOASSAY KIT (K831377)American Diagnostic Corp.1983-06-02
IGE-QUANT DIAGNOSTIC TEST KIT (K831208)Leeco Diagnostics, Inc.1983-05-09
NEW ALLERGEN DISCS FOR USE IN VAST VENT (K830817)Ventrex Laboratories, Inc.1983-04-27
RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E (K830357)Clinetics Corp.1983-03-17
DENSITOMETRIC INHALENT PROFILE SLLER (K830164)Mast Immunosystems1983-03-01
TOTAL IGE-FAST TEST (K823494)Axonics, Inc.1983-01-14
PHADEZYM RAST ALLERGEN DISCS (K823842)Pharmacia, Inc.1983-01-12
PHADEBAS RAST ALLERGEN DISCS (K823841)Pharmacia, Inc.1983-01-12
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY (K823507)Hybritech, Inc.1982-12-28
ALLERCOAT POSITIVE CONTROL SERUM (K823403)Kallestad Laboratories, Inc.1982-12-15
ALLERGENETICS IGE-FAST TEST (K822341)Allergenetics1982-11-10
RAST ALLERCOAT ALLERGEN DISCS (K822613)Kallestad Laboratories, Inc.1982-10-22
VAST VENTREX RAST ALLERGEN DISCS (K822442)Ventrex Laboratories, Inc.1982-09-02
TOTAL IGE DISCS (K822206)Kallestad Laboratories, Inc.1982-08-16
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT (K821092)Clinical Assays, Inc.1982-06-22
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