Home › Device types › DGC
Ige, Antigen, Antiserum, Control
FDA product code DGC · Class 2 · Immunology
101
Registered devices
40
Adverse events
3
Recalls
114
510(k) clearances
Devices with this code
K-ASSAY® Total IgE Reagent — KAMIYA BIOMEDICAL COMPANY, LLCImmunoCAP IgE/ECP/Tryptase Sample Diluent — Phadia ABOrchard Grass Dactylis glomerata — HYCOR BIOMEDICAL LLCIgE — RANDOX LABORATORIES LIMITEDIgE AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.ImmunoCAP IgE/ECP/Tryptase Sample Diluent — Phadia ABAccess Total IgE — Beckman Coulter, Inc.Monobind AccuBind IgE ELISA Kit - 192 Wells — MONOBIND, INC.Potato, White — HYCOR BIOMEDICAL LLCThistle, Russian Salsola kali — HYCOR BIOMEDICAL LLCUP20 Positive Control Reagent — Minaris Medical America, Inc.UP20 Negative Control Reagent — Minaris Medical America, Inc.Immunoglobulin E (IgE) ELISA — DRG International IncSycamore Platanus occidentalis — HYCOR BIOMEDICAL LLCMonobind AccuLite IgE CLIA Kit - 96 Wells — MONOBIND, INC.Cedar, Mountain (Savin) Juniperus sabinoides (syn. Sabina,ashei) — HYCOR BIOMEDICAL LLCARCHITECT — ABBOTT LABORATORIESAntiserum to Human IgE (epsilon specific) — KENT LABORATORIES INCOat Pollen, Cultivated Avena sativa — HYCOR BIOMEDICAL LLCIgE AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.ImmunoCAP Total IgE Anti-IgE — Phadia ABMugwort Artemisia vulgaris — HYCOR BIOMEDICAL LLCTuna — HYCOR BIOMEDICAL LLCRagweed, Giant Ambrosia trifida — HYCOR BIOMEDICAL LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2016-09-07 | Randox Laboratories Ltd. | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum |
| 2009-01-05 | Siemens Medical Solutions Diagnostics | Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper. |
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