DGC — Ige, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DGC
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231151 | kenota | Kenota 1 Total IgE; Kenota 1 (instrument) | May 31, 2024 |
| K214068 | biokit | Quantia IgE | February 21, 2023 |
| K220178 | beckman coulter | Total Immunoglobulin E (IgE) | March 23, 2022 |
| K193493 | siemens healthcare diagnostics | ADVIA Centaur Total IgE (tIgE) | January 15, 2020 |
| K161899 | phadia | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To | July 28, 2016 |
| K133404 | phadia | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L | February 24, 2014 |
| K063425 | dade behring | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT | February 15, 2007 |
| K050493 | biokit | QUANTIA IGE | August 16, 2005 |
| K042241 | kamiya biomedical | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | December 10, 2004 |
| K034057 | adiatec | LACRYTEST | March 9, 2004 |
| K032251 | immunetech corporation | IMMUNETECH TOTAL IGE SYSTEM | December 19, 2003 |
| K024210 | beckman coulter | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | February 24, 2003 |
| K010855 | randox laboratories | RANDOX IGE | May 15, 2001 |
| K002560 | binding site | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | October 26, 2000 |
| K992528 | biocheck | BIOCHECK IGE ELISA, MODEL BC-1035 | September 21, 1999 |
| K991316 | touch scientific | TOUCH TEAR IGE MICROASSAY KIT | August 9, 1999 |
| K991945 | pharmacia and upjohn | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | July 28, 1999 |
| K991787 | dade behring | N LATEX IGE MONO REAGENT | July 7, 1999 |
| K983185 | boehringer mannheim | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | November 12, 1998 |
| K972697 | tosoh medics | AIA-PACK IGE II ASSAY | October 3, 1997 |