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
SPECIFIC IGE CONTROL KIT — HYCOR BIOMEDICAL LLCAIA-PACK IgEII Sample Diluting Solution — TOSOH CORPORATIONImmunoCAP Total IgE Curve Control Strip — Phadia ABBahia Grass Paspalum notatum — HYCOR BIOMEDICAL LLCIgE AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.Brome Grass Bromus inermis — HYCOR BIOMEDICAL LLCMonobind AccuBind IgE ELISA Kit - 192 Wells — MONOBIND, INC.OPTIGEN® Negative Control Reagent — Minaris Medical America, Inc.IgE CAL SET — RANDOX LABORATORIES LIMITEDIgE AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.ARCHITECT — ABBOTT LABORATORIESVelvet Grass Holcus lanatus — HYCOR BIOMEDICAL LLCImmunoCAP Total IgE Curve Controls — Phadia ABK-ASSAY® Total IgE Reagent — KAMIYA BIOMEDICAL COMPANY, LLCHytec Specific/Total IgE Control — HYCOR BIOMEDICAL LLCImmunoCAP IgE/ECP/Tryptase Sample Diluent — Phadia ABARCHITECT — ABBOTT LABORATORIESThistle, Russian Salsola kali — HYCOR BIOMEDICAL LLCPotato, White — HYCOR BIOMEDICAL LLCAntiserum to Human IgE (epsilon specific) — KENT LABORATORIES INCUP20 Positive Control Reagent — Minaris Medical America, Inc.Ragweed, Giant Ambrosia trifida — HYCOR BIOMEDICAL LLCAccess Total IgE Calibrator S0 — Beckman Coulter, Inc.ARCHITECT — ABBOTT LABORATORIES
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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