Product code DGC
- Device name
- Ige, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5510
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024-05-31 |
| K214068 | Quantia IgE | Biokit, S.A. | 2023-02-21 |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-03-23 |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 |
| 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/Sp... | Phadia AB | 2016-07-28 |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | Phadia AB | 2014-02-24 |
| 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 |
| K050493 | QUANTIA IGE | Biokit, S.A. | 2005-08-16 |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Kamiya Biomedical Co. | 2004-12-10 |
| K034057 | LACRYTEST | Adiatec SA | 2004-03-09 |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | 2003-12-19 |
| K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | Beckman Coulter, Inc. | 2003-02-24 |
| K010855 | RANDOX IGE | Randox Laboratories, Ltd. | 2001-05-15 |
| K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | 1999-09-21 |
| K991316 | TOUCH TEAR IGE MICROASSAY KIT | Touch Scientific, Inc. | 1999-08-09 |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | 1999-07-28 |
| K991787 | N LATEX IGE MONO REAGENT | Dade Behring, Inc. | 1999-07-07 |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | 1998-11-12 |
| K972697 | AIA-PACK IGE II ASSAY | Tosoh Medics, Inc. | 1997-10-03 |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Pharmacia, Inc. | 1997-04-23 |
| K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1994-05-17 |
| K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1994-04-21 |
| K933180 | QUANTA LITE MITOCHONDRIA M2 ELISA | Inova Diagnostics, Inc. | 1993-08-05 |
| K930890 | COBAS(R) CORE IGE TOTAL EIA | Roche Diagnostic Systems, Inc. | 1993-08-05 |
| K930984 | ACCESS(R) TOTAL IGE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-09 |
| K923832 | PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION | Kabi Pharmacia, Inc. | 1992-11-25 |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | Medix Biotech, Inc. | 1992-08-05 |
| K920372 | ACS TOTAL IGE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-04-08 |
| K912800 | KALLESTEAD TOTAL IGE MICROPLATE KIT | Bio-Rad Laboratories, Inc. | 1991-07-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870024400 | IgE-XR AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00850054026477 | QMedix™ | Diagnostic Automation, Inc. | 2024-01-31 |
| 00380740153700 | Alinity | ABBOTT LABORATORIES | 2023-10-14 |
| 04048474017885 | Immunoglobulin E (IgE) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-26 |
| 15099590701727 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-05-03 |
| 00840239017888 | Immunoglobulin E (IgE) ELISA | DRG International Inc | 2021-06-07 |
| 00380740156367 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156404 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156282 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00850392007350 | BioCheck IgE EIA Test Kit | BIOCHECK, INC. | 2019-10-08 |
| 07333066000664 | ImmunoCAP Total IgE Conjugate 400 | Phadia AB | 2019-03-29 |
| 07333066019864 | ImmunoCAP Total IgE Conjugate 400 | Phadia AB | 2019-03-29 |
| 07333066000220 | ImmunoCAP Total IgE Curve Control Strip | Phadia AB | 2019-03-28 |
| 07333066000206 | ImmunoCAP Total IgE Conjugate 100 | Phadia AB | 2019-03-28 |
| 07333066019796 | ImmunoCAP Total IgE Calibrator Strip | Phadia AB | 2019-03-28 |
| 07333066019789 | ImmunoCAP Total IgE Curve Control Strip | Phadia AB | 2019-03-28 |
| 07333066019772 | ImmunoCAP Total IgE Conjugate 100 | Phadia AB | 2019-03-28 |
| 00816870020242 | IgE AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020259 | Monobind AccuBind IgE ELISA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020266 | IgE AccuBind ELISA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020273 | IgE AccuBind ELISA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021928 | Monobind AccuLite IgE CLIA Kit - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021935 | IgE AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021942 | IgE AccuLite CLIA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021959 | IgE AccuLite CLIA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 07333066011660 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | Phadia AB | 2016-09-23 |
| 07333066011356 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | Phadia AB | 2016-09-23 |
| 00380740044848 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740030100 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 15099590227029 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |