Product code DGC— Immunology
ALLERCOAT ALLERGEN DISCS
- Classification name
- Ige, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 114
- First cleared
- Most recent
Market context for product code DGC
FDA has cleared devices under product code DGC between 1977 and 2024, filed by 56 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2022
- 2020
- 2016
- 2014
- 2007
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code DGC
Recent clearances under product code DGC
1–100 of 114- K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)
- K214068 — Quantia IgE
- K220178 — Total Immunoglobulin E (IgE)
- K193493 — ADVIA Centaur Total IgE (tIgE)
- 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/Specific IgE Curve Controls
- K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
- K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
- K050493 — QUANTIA IGE
- K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
- K034057 — LACRYTEST
- K032251 — IMMUNETECH TOTAL IGE SYSTEM
- K024210 — IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
- K010855 — RANDOX IGE
- K002560 — SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
- K992528 — BIOCHECK IGE ELISA, MODEL BC-1035
- K991316 — TOUCH TEAR IGE MICROASSAY KIT
- K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
- K991787 — N LATEX IGE MONO REAGENT
- K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
- K972697 — AIA-PACK IGE II ASSAY
- K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
- K940183 — HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
- K934594 — MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
- K930890 — COBAS(R) CORE IGE TOTAL EIA
- K933180 — QUANTA LITE MITOCHONDRIA M2 ELISA
- K930984 — ACCESS(R) TOTAL IGE ASSAY
- K923832 — PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
- K922047 — IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
- K920372 — ACS TOTAL IGE IMMUNOASSAY
- K912800 — KALLESTEAD TOTAL IGE MICROPLATE KIT
- K910419 — BIOCLONE'S ELEGANCE IGE ELISA KIT
- K911631 — PHARMACIA SPECIFIC IGE CONTROL
- K910082 — POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
- K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
- K903738 — QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
- K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY
- K900108 — 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
- K900244 — 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
- K895914 — ABBOTT IMX IGE
- K895004 — MILENIA(TM) TOTAL IGE (MKIE1,5)
- K895294 — PROGENE IGE BEAD EIA
- K893951 — PHARMACIA CAP SYSTEM IGE RIA AND FEIA
- K892197 — ALATOP (TM) CATALOG # AKAL1
- K890530 — N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
- K885307 — FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
- K884545 — DELFIA (TM) HIGE KIT
- K882625 — PHARMACIA IGE RIA ULTRA
- K882626 — PHARMACIA IGE EIA ULTRA
- K881892 — PHARMACIA IGE RIACT
- K874541 — RRT TOTAL IGE TEST KIT
- K874406 — IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
- K872913 — ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
- K872968 — ULTRASCAN IGE ASSAY KIT
- K864142 — UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
- K863858 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
- K863822 — ENZYMUN-TEST(R) IGE
- K862174 — TIMOTHY ALLERGEN DISC
- K862368 — AMPLIFIED ELISA IGE KIT
- K861171 — QUIDEL ALLERGY SCREEN
- K860032 — TOTAL IGE-IRMA RIA KIT
- K860033 — EIA MONOCLONAL TOTAL IGE KIT
- K852878 — THE DPC MONOCLONAL EIA TOTAL IGE KIT
- K853025 — IMAGE-IGE
- K852268 — QUANTICLONE IGE RADIOIMMUNASSAY
- K851156 — PHARMACIA IGE RIA MODIFIED
- K850786 — TOTAL HIGE ENZYME IMMUNOASSAY
- K843369 — AGGLUTINATION TEST FOR TOTAL IGE
- K843710 — ELISA FOR TOTAL IGE
- K843408 — ENCORE IGE REAGENT
- K841642 — MAST LUMINESCENT ALLERGY SYS
- K841824 — PHARMACIA IGE RIA
- K841829 — PHADEBAS RAST PHADEZYM RAST ALLERGEN
- K842125 — ALLERCOAT ALLERGEN DISCS
- K841651 — VAST VENTREX RAST ALL
- K840476 — PHADEXACT SERUM, TOTAL IGE CONTROLS
- K840674 — SENSIBEAD EIA IGE KIT
- K840538 — PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
- K834594 — TOTAL IGE FAST TEST
- K833419 — LABELED 125I ANTI-IGE
- K833969 — MAST TOTAL IGE
- K832345 — POLYSTYRENE MICROTITER WELL IMMUNOSOR
- K832360 — ABBOTT IGE EIA
- K832218 — ALLERGEN CONTROL INHALENT
- K831326 — ALLERCOAT ALLERGEN DISCS
- K831377 — IGE RADIOIMMUNOASSAY KIT
- K831485 — VENTRE/ZYME IGE KIT
- K831208 — IGE-QUANT DIAGNOSTIC TEST KIT
- K830817 — NEW ALLERGEN DISCS FOR USE IN VAST VENT
- K830357 — RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
- K830164 — DENSITOMETRIC INHALENT PROFILE SLLER
- K823494 — TOTAL IGE-FAST TEST
- K823841 — PHADEBAS RAST ALLERGEN DISCS
- K823842 — PHADEZYM RAST ALLERGEN DISCS
- K823507 — TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
- K823403 — ALLERCOAT POSITIVE CONTROL SERUM
- K822341 — ALLERGENETICS IGE-FAST TEST
- K822613 — RAST ALLERCOAT ALLERGEN DISCS
- K822442 — VAST VENTREX RAST ALLERGEN DISCS
- K822206 — TOTAL IGE DISCS
- K821092 — GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
Data sourced from openFDA. This site is unofficial and independent of the FDA.