Panels › Immunology › Product code DGC · Class 2
Ige, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (114 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DGC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 16 | 0 |
| Ventrex Laboratories, Inc. | 12 | 0 |
| Kallestad Laboratories, Inc. | 8 | 0 |
| Diagnostic Products Corp. | 6 | 0 |
| Hybritech, Inc. | 4 | 0 |
| Allergenetics | 3 | 0 |
| Mast Immunosystems | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| 3M Company | 2 | 0 |
| Abbott Laboratories | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2024 | K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) Kenota, Inc., CA | DGC |
| Feb 21, 2023 | K214068 | Quantia IgE Biokit, S.A., ES | DGC |
| Mar 23, 2022 | K220178 | Total Immunoglobulin E (IgE) Beckman Coulter, Inc. | DGC |
| Jan 15, 2020 | K193493 | ADVIA Centaur Total IgE (tIgE) Siemens Healthcare Diagnostics, Inc. | DGC |
| Jul 28, 2016 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Cont Phadia AB, SE | DGC |
| Feb 24, 2014 | K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH Phadia AB | DGC |
| Feb 15, 2007 | K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH Dade Behring, Inc. | DGC |
| Aug 16, 2005 | K050493 | QUANTIA IGE Biokit, S.A., ES | DGC |
| Dec 10, 2004 | K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C Kamiya Biomedical Co. | DGC |
| Mar 9, 2004 | K034057 | LACRYTEST Adiatec SA, FR | DGC |
| Dec 19, 2003 | K032251 | IMMUNETECH TOTAL IGE SYSTEM Immunetech Corporation | DGC |
| Feb 24, 2003 | K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR Beckman Coulter, Inc. | DGC |
| May 15, 2001 | K010855 | RANDOX IGE Randox Laboratories, Ltd., GB | DGC |
| Oct 26, 2000 | K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. | DGC |
| Sep 21, 1999 | K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 Biocheck, Inc. | DGC |
| Aug 9, 1999 | K991316 | TOUCH TEAR IGE MICROASSAY KIT Touch Scientific, Inc. | DGC |
| Jul 28, 1999 | K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 Pharmacia & Upjohn Co. | DGC |
| Jul 7, 1999 | K991787 | N LATEX IGE MONO REAGENT Dade Behring, Inc. | DGC |
| Nov 12, 1998 | K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST Boehringer Mannheim Corp. | DGC |
| Oct 3, 1997 | K972697 | AIA-PACK IGE II ASSAY Tosoh Medics, Inc. | DGC |
| Apr 23, 1997 | K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH Pharmacia, Inc. | DGC |
| May 17, 1994 | K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. | DGC |
| Apr 21, 1994 | K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. | DGC |
| Aug 5, 1993 | K933180 | QUANTA LITE MITOCHONDRIA M2 ELISA Inova Diagnostics, Inc. | DGC |
| Aug 5, 1993 | K930890 | COBAS(R) CORE IGE TOTAL EIA Roche Diagnostic Systems, Inc. | DGC |
| Jun 9, 1993 | K930984 | ACCESS(R) TOTAL IGE ASSAY Bio-Rad Laboratories, Inc. | DGC |
| Nov 25, 1992 | K923832 | PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION Kabi Pharmacia, Inc. | DGC |
| Aug 5, 1992 | K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 Medix Biotech, Inc. | DGC |
| Apr 8, 1992 | K920372 | ACS TOTAL IGE IMMUNOASSAY Ciba Corning Diagnostics Corp. | DGC |
| Jul 25, 1991 | K912800 | KALLESTEAD TOTAL IGE MICROPLATE KIT Bio-Rad Laboratories, Inc. | DGC |
| Jun 21, 1991 | K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT Bioclone Australia Pty , Ltd. | DGC |
| Apr 24, 1991 | K911631 | PHARMACIA SPECIFIC IGE CONTROL Pharmacia, Inc. | DGC |
| Mar 12, 1991 | K910082 | POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK Quidel Corp. | DGC |
| Feb 21, 1991 | K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY Ventrex Laboratories, Inc. | DGC |
| Oct 15, 1990 | K903738 | QUIDEL ALLERGEN SCREEN POSITIVE CONTROL Quidel Corp. | DGC |
| Aug 2, 1990 | K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY London Diagnostics, Inc. | DGC |
| Feb 21, 1990 | K900244 | 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 3M Company | DGC |
| Feb 21, 1990 | K900108 | 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 3M Company | DGC |
| Nov 13, 1989 | K895914 | ABBOTT IMX IGE Abbott Laboratories | DGC |
| Sep 28, 1989 | K895004 | MILENIA(TM) TOTAL IGE (MKIE1,5) Diagnostic Products Corp. | DGC |
| Sep 21, 1989 | K895294 | PROGENE IGE BEAD EIA Progene Corp. | DGC |
| Jul 14, 1989 | K893951 | PHARMACIA CAP SYSTEM IGE RIA AND FEIA Pharmacia, Inc. | DGC |
| Jun 2, 1989 | K892197 | ALATOP (TM) CATALOG # AKAL1 Diagnostic Products Corp. | DGC |
| Mar 27, 1989 | K890530 | N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) Behring Diagnostics, Inc. | DGC |
| Mar 8, 1989 | K885307 | FLIPSCREEN (TM) TOTAL E IMMUNOASSAY Alerchek, Inc. | DGC |
| Nov 10, 1988 | K884545 | DELFIA (TM) HIGE KIT Pharmacia, Inc. | DGC |
| Aug 8, 1988 | K882625 | PHARMACIA IGE RIA ULTRA Pharmacia, Inc. | DGC |
| Aug 4, 1988 | K882626 | PHARMACIA IGE EIA ULTRA Pharmacia, Inc. | DGC |
| Jun 10, 1988 | K881892 | PHARMACIA IGE RIACT Pharmacia, Inc. | DGC |
| Feb 17, 1988 | K874541 | RRT TOTAL IGE TEST KIT Incstar Corp. | DGC |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.