Ige, Antigen, Antiserum, Control
FDA product code DGC · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
114510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Pharmacia, Inc. 16
- Ventrex Laboratories, Inc. 12
- Kallestad Laboratories, Inc. 8
- Diagnostic Products Corp. 6
- Hybritech, Inc. 4
- Mast Immunosystems 3
- Quidel Corp. 3
- Allergenetics 3
- 3M Company 2
- Bio-Rad Laboratories, Inc. 2
- Phadia AB 2
- Dade Behring, Inc. 2
- Abbott Laboratories 2
- Medix Biotech, Inc. 2
- Beckman Coulter Inc. 2
- Scientific Research 2
- Boehringer Mannheim Corp. 2
- Biokit, S.A. 2
- Ciba Corning Diagnostics Corp. 2
- Kenota, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument)DGC · Dual Track | Kenota, Inc. | 05/31/2024SE |
| K214068 | Quantia IgEDGC · Special | Biokit, S.A. | 02/21/2023SE |
| K220178 | Total Immunoglobulin E (IgE)DGC · Traditional | Beckman Coulter, Inc. | 03/23/2022SE |
| K193493 | ADVIA Centaur Total IgE (tIgE)DGC · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/15/2020SE |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…DGC · Special | Phadia AB | 07/28/2016SE |
| K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHDGC · Special | Phadia AB | 02/24/2014SE |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | Dade Behring, Inc. | 02/15/2007SE |
| K050493 | Quantia IgeDGC · Traditional | Biokit, S.A. | 08/16/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
| K034057 | LacrytestDGC · Traditional | Adiatec SA | 03/09/2004SE |
| K032251 | Immunetech Total Ige SystemDGC · Traditional | Immunetech Corporation | 12/19/2003SE |
| K024210 | Immage Systems Total Immunoglobulin E (Ige) Reagent Immage Ige CalibratorDGC · Traditional | Beckman Coulter, Inc. | 02/24/2003SE |
| K010855 | Randox IgeDGC · Traditional | Randox Laboratories, Ltd. | 05/15/2001SE |
| K002560 | Sheep Anti-Human Ige Immunofixation Grade KitDGC · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
| K992528 | Biocheck Ige Elisa, Model BC-1035DGC · Traditional | Biocheck, Inc. | 09/21/1999SE |
| K991316 | Touch Tear Ige Microassay KitDGC · Traditional | Touch Scientific, Inc. | 08/09/1999SE |
| K991945 | Pharmacia Cap System Ige Feia, Model 10-9395-01DGC · Traditional | Pharmacia & Upjohn Co. | 07/28/1999SE |
| K991787 | N Latex Ige Mono ReagentDGC · Traditional | Dade Behring, Inc. | 07/07/1999SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | Boehringer Mannheim Corp. | 11/12/1998SE |
| K972697 | Aia-Pack Ige II AssayDGC · Traditional | Tosoh Medics, Inc. | 10/03/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | Pharmacia, Inc. | 04/23/1997SE |
| K940183 | Hy-Tec Total Ige Enzyme ImmunoassayDGC · Traditional | Hycor Biomedical, Inc. | 05/17/1994SE |
| K934594 | Magic Lite SQ Specific Ige Immunoassay SystemDGC · Traditional | Ciba Corning Diagnostics Corp. | 04/21/1994SE |
| K933180 | Quanta Lite Mitochondria M2 ElisaDGC · Traditional | Inova Diagnostics, Inc. | 08/05/1993SE |
| K930890 | Cobas(R) Core Ige Total EiaDGC · Traditional | Roche Diagnostic Systems, Inc. | 08/05/1993SE |
| K930984 | Access(R) Total Ige AssayDGC · Traditional | Bio-Rad Laboratories, Inc. | 06/09/1993SE |
| K923832 | Pharmacia Cap System Ige Feia -- ModificationDGC · Traditional | Kabi Pharmacia, Inc. | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | Medix Biotech, Inc. | 08/05/1992SE |
| K920372 | Acs Total Ige ImmunoassayDGC · Traditional | Ciba Corning Diagnostics Corp. | 04/08/1992SE |
| K912800 | Kallestead Total Ige Microplate KitDGC · Traditional | Bio-Rad Laboratories, Inc. | 07/25/1991SE |
| K910419 | Bioclone's Elegance Ige Elisa KitDGC · Traditional | Bioclone Australia Pty , Ltd. | 06/21/1991SE |
| K911631 | Pharmacia Specific Ige ControlDGC · Traditional | Pharmacia, Inc. | 04/24/1991SE |
| K910082 | Positive Control Pad for Total Ige Test DipstickDGC · Traditional | Quidel Corp. | 03/12/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | Ventrex Laboratories, Inc. | 02/21/1991SE |
| K903738 | Quidel Allergen Screen Positive ControlDGC · Traditional | Quidel Corp. | 10/15/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | London Diagnostics, Inc. | 08/02/1990SE |
| K900244 | 3M Multi-Allergen Ige Fastscreen(Tm) S8DGC · Traditional | 3M Company | 02/21/1990SE |
| K900108 | 3M Multi-Aller. Ige Fastscreen S9 W1,6,9,10,11,12DGC · Traditional | 3M Company | 02/21/1990SE |
| K895914 | Abbott Imx IgeDGC · Traditional | Abbott Laboratories | 11/13/1989SE |
| K895004 | Milenia(Tm) Total Ige (MKIE1,5)DGC · Traditional | Diagnostic Products Corp. | 09/28/1989SE |
| K895294 | Progene Ige Bead EiaDGC · Traditional | Progene Corp. | 09/21/1989SE |
| K893951 | Pharmacia Cap System Ige Ria and FeiaDGC · Traditional | Pharmacia, Inc. | 07/14/1989SE |
| K892197 | Alatop (TM) Catalog # AKAL1DGC · Traditional | Diagnostic Products Corp. | 06/02/1989SE |
| K890530 | N Latex Ige Kit (Immunoglobulin E Reagents)DGC · Traditional | Behring Diagnostics, Inc. | 03/27/1989SE |
| K885307 | Flipscreen (TM) Total E ImmunoassayDGC · Traditional | Alerchek, Inc. | 03/08/1989SE |
| K884545 | Delfia (TM) Hige KitDGC · Traditional | Pharmacia, Inc. | 11/10/1988SE |
| K882625 | Pharmacia Ige Ria UltraDGC · Traditional | Pharmacia, Inc. | 08/08/1988SE |
| K882626 | Pharmacia Ige Eia UltraDGC · Traditional | Pharmacia, Inc. | 08/04/1988SE |
| K881892 | Pharmacia Ige RiactDGC · Traditional | Pharmacia, Inc. | 06/10/1988SE |
| K874541 | RRT Total Ige Test KitDGC · Traditional | Incstar Corp. | 02/17/1988SE |
| K874406 | Ige Enzyme Immunoassay Test Kit No. MB-1064DGC · Traditional | Medix Biotech, Inc. | 11/25/1987SE |
| K872913 | Alleia Total Ige Irma W/Mono. Anti. Rkie 1,2,5DGC · Traditional | Diagnostic Products Corp. | 09/10/1987SE |
| K872968 | Ultrascan Ige Assay KitDGC · Traditional | Specialty Medical Industries, Inc. | 08/28/1987SE |
| K864142 | Ubi Magiwel(Tm) Ige Quantitative and QualitativeDGC · Traditional | United Biotech, Inc. | 12/03/1986SE |
| K863858 | Tandem-M Immunoenzymetric Assay for Ige--DGC · Traditional | Hybritech, Inc. | 11/03/1986SE |
| K863822 | Enzymun-Test(R) IgeDGC · Traditional | Boehringer Mannheim Corp. | 10/29/1986SE |
| K862174 | Timothy Allergen DiscDGC · Traditional | Immuno Nuclear Corp. | 08/06/1986SE |
| K862368 | Amplified Elisa Ige KitDGC · Traditional | Allertec, Inc. | 07/03/1986SE |
| K861171 | Quidel Allergy ScreenDGC · Traditional | Quidel Corp. | 04/25/1986SE |
| K860032 | Total Ige-Irma Ria KitDGC · Traditional | Diagnostic Products Corp. | 04/11/1986SE |
| K860033 | Eia Monoclonal Total Ige KitDGC · Traditional | Diagnostic Products Corp. | 04/07/1986SE |
| K852878 | The DPC Monoclonal Eia Total Ige KitDGC · Traditional | Diagnostic Products Corp. | 08/28/1985SE |
| K853025 | Image-IgeDGC · Traditional | Clinical Reference Laboratory, Inc. | 08/22/1985SE |
| K852268 | Quanticlone Ige RadioimmunassayDGC · Traditional | Kallestad Laboratories, Inc. | 07/10/1985SE |
| K851156 | Pharmacia Ige Ria ModifiedDGC · Traditional | Pharmacia, Inc. | 04/25/1985SE |
| K850786 | Total Hige Enzyme ImmunoassayDGC · Traditional | Nms Pharmaceuticals, Inc. | 04/12/1985SE |
| K843369 | Agglutination Test for Total IgeDGC · Traditional | Scientific Research | 11/14/1984SE |
| K843710 | Elisa for Total IgeDGC · Traditional | Scientific Research | 10/22/1984SE |
| K843408 | Encore Ige ReagentDGC · Traditional | Hybritech, Inc. | 10/01/1984SE |
| K842125 | Allercoat Allergen DiscsDGC · Traditional | Kallestad Laboratories, Inc. | 06/07/1984SE |
| K841829 | Phadebas Rast Phadezym Rast AllergenDGC · Traditional | Pharmacia, Inc. | 06/07/1984SE |
| K841824 | Pharmacia Ige RiaDGC · Traditional | Pharmacia, Inc. | 06/07/1984SE |
| K841642 | Mast Luminescent Allergy SysDGC · Traditional | Mast Immunosystems | 06/07/1984SE |
| K841651 | Vast Ventrex Rast AllDGC · Traditional | Ventrex Laboratories, Inc. | 06/01/1984SE |
| K840476 | Phadexact Serum, Total Ige ControlsDGC · Traditional | Pharmacia, Inc. | 05/21/1984SE |
| K840674 | Sensibead Eia Ige KitDGC · Traditional | Terumo Medical Corp. | 04/04/1984SE |
| K840538 | Phadexact Serum, Allergen Specific IgeDGC · Traditional | Pharmacia, Inc. | 03/23/1984SE |
| K834594 | Total Ige Fast TestDGC · Traditional | Allergenetics | 02/10/1984SE |
| K833419 | Labeled 125I Anti-IgeDGC · Traditional | Allergenetics | 02/03/1984SE |
| K833969 | Mast Total IgeDGC · Traditional | Mast Immunosystems | 01/04/1984SE |
| K832345 | Polystyrene Microtiter Well ImmunosorDGC · Traditional | Diagnostic Reagent Tech. | 11/25/1983SE |
| K832360 | Abbott Ige EiaDGC · Traditional | Abbott Laboratories | 10/14/1983SE |
| K832218 | Allergen Control InhalentDGC · Traditional | Ventrex Laboratories, Inc. | 09/20/1983SE |
| K831485 | Ventre/Zyme Ige KitDGC · Traditional | Ventrex Laboratories, Inc. | 06/02/1983SE |
| K831377 | Ige Radioimmunoassay KitDGC · Traditional | American Diagnostic Corp. | 06/02/1983SE |
| K831326 | Allercoat Allergen DiscsDGC · Traditional | Kallestad Laboratories, Inc. | 06/02/1983SE |
| K831208 | Ige-Quant Diagnostic Test KitDGC · Traditional | Leeco Diagnostics, Inc. | 05/09/1983SE |
| K830817 | New Allergen Discs for Use in Vast VentDGC · Traditional | Ventrex Laboratories, Inc. | 04/27/1983SE |
| K830357 | Radioimmunoassay Immunoglobulins D.EDGC · Traditional | Clinetics Corp. | 03/17/1983SE |
| K830164 | Densitometric Inhalent Profile SllerDGC · Traditional | Mast Immunosystems | 03/01/1983SE |
| K823494 | Total Ige-Fast TestDGC · Traditional | Axonics, Inc. | 01/14/1983SE |
| K823842 | Phadezym Rast Allergen DiscsDGC · Traditional | Pharmacia, Inc. | 01/12/1983SE |
| K823841 | Phadebas Rast Allergen DiscsDGC · Traditional | Pharmacia, Inc. | 01/12/1983SE |
| K823507 | Tandem-E -Ige Immunoezymetric AssayDGC · Traditional | Hybritech, Inc. | 12/28/1982SE |
| K823403 | Allercoat Positive Control SerumDGC · Traditional | Kallestad Laboratories, Inc. | 12/15/1982SE |
| K822341 | Allergenetics Ige-Fast TestDGC · Traditional | Allergenetics | 11/10/1982SE |
| K822613 | Rast Allercoat Allergen DiscsDGC · Traditional | Kallestad Laboratories, Inc. | 10/22/1982SE |
| K822442 | Vast Ventrex Rast Allergen DiscsDGC · Traditional | Ventrex Laboratories, Inc. | 09/02/1982SE |
| K822206 | Total Ige DiscsDGC · Traditional | Kallestad Laboratories, Inc. | 08/16/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | Clinical Assays, Inc. | 06/22/1982SE |
| K820978 | Ventre/Spec Allergen Control-InhalantDGC · Traditional | Ventrex Laboratories, Inc. | 06/11/1982SE |
| K820977 | Ventre/Spec Allergen Control-Molds/FoodDGC · Traditional | Ventrex Laboratories, Inc. | 06/11/1982SE |
| K821615 | Vast Ventrex PD Ige Ria Test SetDGC · Traditional | Ventrex Laboratories, Inc. | 06/10/1982SE |
| K820897 | Ventre/Spec Ige ControlsDGC · Traditional | Ventrex Laboratories, Inc. | 05/05/1982SE |
| K820896 | Ventrex 125I Anti-Ige Allergy IsotopeDGC · Traditional | Ventrex Laboratories, Inc. | 04/21/1982SE |
| K813189 | Phadebas/Phadezym Ige ReagentsDGC · Traditional | Pharmacia, Inc. | 12/31/1981SE |
| K811559 | Ventre/Sep Ige Ria Test SetDGC · Traditional | Ventrex Laboratories, Inc. | 07/10/1981SE |
| K811545 | Kallestad Quantitope Low Level Ige ReagDGC · Traditional | Kallestad Laboratories, Inc. | 06/24/1981SE |
| K802913 | Tan Dem* - Ige KitDGC · Traditional | Hybritech, Inc. | 05/29/1981SE |
| K810507 | Phadezym Ige Prist TestDGC · Traditional | Pharmacia, Inc. | 03/20/1981SE |
| K801019 | 125I-IGE Radioimmunoassay KitDGC · Traditional | Bio-Ria | 05/20/1980SE |
| K781904 | Ria Kit, Quantitope IgeDGC · Traditional | Kallestad Laboratories, Inc. | 02/08/1979SE |
| K780753 | Las-R Human Ige TestDGC · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 06/06/1978SE |
| K771238 | Rid Plates & Intensi. for Human Ige EtcDGC · Traditional | G.D. Searle and Co. | 07/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2097-2018 Class II | ST-AIA PACK IGE II; Part Number: 025295 Assay, AllergyAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-0050-2017 Class II | IgE Calibrator SeriesAccording to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been… | Randox Laboratories Ltd. | 09/07/2016Terminated |
| Z-1399-2009 | Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002.…Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a… | Siemens Medical Solutions Diagnostics | 01/05/2009Terminated |