FDA Product Code
FDA Product Code DGC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 114 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024-05-31 | Dual Track | PDF ↗ |
| K214068 | Quantia IgE | Biokit, S.A. | 2023-02-21 | Special | PDF ↗ |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-03-23 | Traditional | PDF ↗ |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 | Traditional | PDF ↗ |
| K161899 | 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 | Phadia AB | 2016-07-28 | Special | PDF ↗ |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | Phadia AB | 2014-02-24 | Special | PDF ↗ |
| K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | 2007-02-15 | Traditional | PDF ↗ |
| K050493 | QUANTIA IGE | Biokit, S.A. | 2005-08-16 | Traditional | PDF ↗ |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Kamiya Biomedical Co. | 2004-12-10 | Traditional | PDF ↗ |
| K034057 | LACRYTEST | Adiatec SA | 2004-03-09 | Traditional | PDF ↗ |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | 2003-12-19 | Traditional | PDF ↗ |
| K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | Beckman Coulter, Inc. | 2003-02-24 | Traditional | PDF ↗ |
| K010855 | RANDOX IGE | Randox Laboratories, Ltd. | 2001-05-15 | Traditional | PDF ↗ |
| K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 | Traditional | PDF ↗ |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | 1999-09-21 | Traditional | PDF ↗ |
| K991316 | TOUCH TEAR IGE MICROASSAY KIT | Touch Scientific, Inc. | 1999-08-09 | Traditional | PDF ↗ |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | 1999-07-28 | Traditional | PDF ↗ |
| K991787 | N LATEX IGE MONO REAGENT | Dade Behring, Inc. | 1999-07-07 | Traditional | PDF ↗ |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | 1998-11-12 | Traditional | PDF ↗ |
| K972697 | AIA-PACK IGE II ASSAY | Tosoh Medics, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Pharmacia, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1994-04-21 | Traditional | PDF ↗ |
| K930890 | COBAS(R) CORE IGE TOTAL EIA | Roche Diagnostic Systems, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K933180 | QUANTA LITE MITOCHONDRIA M2 ELISA | Inova Diagnostics, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K930984 | ACCESS(R) TOTAL IGE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-09 | Traditional | PDF ↗ |
| K923832 | PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION | Kabi Pharmacia, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | Medix Biotech, Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K920372 | ACS TOTAL IGE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-04-08 | Traditional | PDF ↗ |
| K912800 | KALLESTEAD TOTAL IGE MICROPLATE KIT | Bio-Rad Laboratories, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT | Bioclone Australia Pty , Ltd. | 1991-06-21 | Traditional | PDF ↗ |
| K911631 | PHARMACIA SPECIFIC IGE CONTROL | Pharmacia, Inc. | 1991-04-24 | Traditional | PDF ↗ |
| K910082 | POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK | Quidel Corp. | 1991-03-12 | Traditional | PDF ↗ |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | Ventrex Laboratories, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K903738 | QUIDEL ALLERGEN SCREEN POSITIVE CONTROL | Quidel Corp. | 1990-10-15 | Traditional | PDF ↗ |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | London Diagnostics, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K900244 | 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 | 3M Company | 1990-02-21 | Traditional | PDF ↗ |
| K900108 | 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 | 3M Company | 1990-02-21 | Traditional | PDF ↗ |
| K895914 | ABBOTT IMX IGE | Abbott Laboratories | 1989-11-13 | Traditional | PDF ↗ |
| K895004 | MILENIA(TM) TOTAL IGE (MKIE1,5) | Diagnostic Products Corp. | 1989-09-28 | Traditional | PDF ↗ |
| K895294 | PROGENE IGE BEAD EIA | Progene Corp. | 1989-09-21 | Traditional | PDF ↗ |
| K893951 | PHARMACIA CAP SYSTEM IGE RIA AND FEIA | Pharmacia, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K892197 | ALATOP (TM) CATALOG # AKAL1 | Diagnostic Products Corp. | 1989-06-02 | Traditional | PDF ↗ |
| K890530 | N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) | Behring Diagnostics, Inc. | 1989-03-27 | Traditional | PDF ↗ |
| K885307 | FLIPSCREEN (TM) TOTAL E IMMUNOASSAY | Alerchek, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K884545 | DELFIA (TM) HIGE KIT | Pharmacia, Inc. | 1988-11-10 | Traditional | PDF ↗ |
| K882625 | PHARMACIA IGE RIA ULTRA | Pharmacia, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K882626 | PHARMACIA IGE EIA ULTRA | Pharmacia, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K881892 | PHARMACIA IGE RIACT | Pharmacia, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K874541 | RRT TOTAL IGE TEST KIT | Incstar Corp. | 1988-02-17 | Traditional | PDF ↗ |
| K874406 | IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 | Medix Biotech, Inc. | 1987-11-25 | Traditional | PDF ↗ |
| K872913 | ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 | Diagnostic Products Corp. | 1987-09-10 | Traditional | PDF ↗ |
| K872968 | ULTRASCAN IGE ASSAY KIT | Specialty Medical Industries, Inc. | 1987-08-28 | Traditional | PDF ↗ |
| K864142 | UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE | United Biotech, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K863858 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- | Hybritech, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K863822 | ENZYMUN-TEST(R) IGE | Boehringer Mannheim Corp. | 1986-10-29 | Traditional | PDF ↗ |
| K862174 | TIMOTHY ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-06 | Traditional | PDF ↗ |
| K862368 | AMPLIFIED ELISA IGE KIT | Allertec, Inc. | 1986-07-03 | Traditional | PDF ↗ |
| K861171 | QUIDEL ALLERGY SCREEN | Quidel Corp. | 1986-04-25 | Traditional | PDF ↗ |
| K860032 | TOTAL IGE-IRMA RIA KIT | Diagnostic Products Corp. | 1986-04-11 | Traditional | PDF ↗ |
| K860033 | EIA MONOCLONAL TOTAL IGE KIT | Diagnostic Products Corp. | 1986-04-07 | Traditional | PDF ↗ |
| K852878 | THE DPC MONOCLONAL EIA TOTAL IGE KIT | Diagnostic Products Corp. | 1985-08-28 | Traditional | PDF ↗ |
| K853025 | IMAGE-IGE | Clinical Reference Laboratory, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K852268 | QUANTICLONE IGE RADIOIMMUNASSAY | Kallestad Laboratories, Inc. | 1985-07-10 | Traditional | PDF ↗ |
| K851156 | PHARMACIA IGE RIA MODIFIED | Pharmacia, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850786 | TOTAL HIGE ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-04-12 | Traditional | PDF ↗ |
| K843369 | AGGLUTINATION TEST FOR TOTAL IGE | Scientific Research | 1984-11-14 | Traditional | PDF ↗ |
| K843710 | ELISA FOR TOTAL IGE | Scientific Research | 1984-10-22 | Traditional | PDF ↗ |
| K843408 | ENCORE IGE REAGENT | Hybritech, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K841829 | PHADEBAS RAST PHADEZYM RAST ALLERGEN | Pharmacia, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841824 | PHARMACIA IGE RIA | Pharmacia, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841642 | MAST LUMINESCENT ALLERGY SYS | Mast Immunosystems | 1984-06-07 | Traditional | PDF ↗ |
| K842125 | ALLERCOAT ALLERGEN DISCS | Kallestad Laboratories, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841651 | VAST VENTREX RAST ALL | Ventrex Laboratories, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K840476 | PHADEXACT SERUM, TOTAL IGE CONTROLS | Pharmacia, Inc. | 1984-05-21 | Traditional | PDF ↗ |
| K840674 | SENSIBEAD EIA IGE KIT | Terumo Medical Corp. | 1984-04-04 | Traditional | PDF ↗ |
| K840538 | PHADEXACT SERUM, ALLERGEN SPECIFIC IGE | Pharmacia, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834594 | TOTAL IGE FAST TEST | Allergenetics | 1984-02-10 | Traditional | PDF ↗ |
| K833419 | LABELED 125I ANTI-IGE | Allergenetics | 1984-02-03 | Traditional | PDF ↗ |
| K833969 | MAST TOTAL IGE | Mast Immunosystems | 1984-01-04 | Traditional | PDF ↗ |
| K832345 | POLYSTYRENE MICROTITER WELL IMMUNOSOR | Diagnostic Reagent Tech. | 1983-11-25 | Traditional | PDF ↗ |
| K832360 | ABBOTT IGE EIA | Abbott Laboratories | 1983-10-14 | Traditional | PDF ↗ |
| K832218 | ALLERGEN CONTROL INHALENT | Ventrex Laboratories, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K831326 | ALLERCOAT ALLERGEN DISCS | Kallestad Laboratories, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K831485 | VENTRE/ZYME IGE KIT | Ventrex Laboratories, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K831377 | IGE RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K831208 | IGE-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830817 | NEW ALLERGEN DISCS FOR USE IN VAST VENT | Ventrex Laboratories, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K830357 | RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E | Clinetics Corp. | 1983-03-17 | Traditional | PDF ↗ |
| K830164 | DENSITOMETRIC INHALENT PROFILE SLLER | Mast Immunosystems | 1983-03-01 | Traditional | PDF ↗ |
| K823494 | TOTAL IGE-FAST TEST | Axonics, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823841 | PHADEBAS RAST ALLERGEN DISCS | Pharmacia, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K823842 | PHADEZYM RAST ALLERGEN DISCS | Pharmacia, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K823507 | TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY | Hybritech, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823403 | ALLERCOAT POSITIVE CONTROL SERUM | Kallestad Laboratories, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K822341 | ALLERGENETICS IGE-FAST TEST | Allergenetics | 1982-11-10 | Traditional | PDF ↗ |
| K822613 | RAST ALLERCOAT ALLERGEN DISCS | Kallestad Laboratories, Inc. | 1982-10-22 | Traditional | PDF ↗ |
| K822442 | VAST VENTREX RAST ALLERGEN DISCS | Ventrex Laboratories, Inc. | 1982-09-02 | Traditional | PDF ↗ |
| K822206 | TOTAL IGE DISCS | Kallestad Laboratories, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | Clinical Assays, Inc. | 1982-06-22 | Traditional | PDF ↗ |
Product code DGC · Class II · Immunology. Data: openFDA.