Igg, Antigen, Antiserum, Control
FDA product code DEW · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
76510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Kent Laboratories, Inc. 5
- Dako Corp. 4
- Icl Scientific 4
- Beckman Instruments, Inc. 4
- Helena Laboratories 3
- Abbott Laboratories 3
- Diagnostica, Inc. 3
- Gelco Diagnostics, Inc. 2
- Technicon Instruments Corp. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- Scripps-Miles, Inc. 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Roche Diagnostics Corp. 2
- Kallestad Laboratories, Inc. 2
- Wako Chemicals USA, Inc. 2
- J.T. Baker Chemical Co. 1
- Protos Laboratories 1
- Electro-Nucleonics Laboratories, Inc. 1
- Gelman Instrument Co. 1
- Organon, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050113 | Tina-Quant Igg GEN.2DEW · Traditional | Roche Diagnostics Corp. | 02/08/2005SE |
| K040434 | Roche Diagnostics Tina-Quant Igg GEN.2DEW · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K010617 | Spife Ife Calibrator and Control KitDEW · Traditional | Helena Laboratories | 03/15/2001SE |
| K993928 | Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin StandardDEW · Traditional | Wako Chemicals USA, Inc. | 01/18/2000SE |
| K993281 | K-Assay IggDEW · Traditional | Kamiya Biomedical Co. | 11/09/1999SE |
| K983221 | IggDEW · Traditional | Abbott Laboratories | 11/04/1998SE |
| K965108 | Synchron LX Systems Immunoglobulin G/A/M ReagentDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963974 | Image-Immunochemistry System Urine ImmunoglobulinDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)DEW · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K962202 | Quantex IggDEW · Traditional | Instrumentation Laboratory CO | 09/26/1996SE |
| K955798 | Igg Immunoturbidimetric & CalibratorDEW · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K951635 | Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator…DEW · Traditional | Beckman Instruments, Inc. | 05/15/1995SE |
| K943997 | Behring Nephelometer IIDEW · Traditional | Behring Diagnostics, Inc. | 10/03/1994SE |
| K934324 | Ot Igg SorbentDEW · Traditional | Organon Teknika Corp. | 04/21/1994SE |
| K933314 | Radias Ferritin Enzyme ImmunoassayDEW · Traditional | Bio-Rad | 09/08/1993SE |
| K924197 | Zorba(Tm) Igg Removal ReagentDEW · Traditional | Zeus Scientific, Inc. | 12/15/1992SE |
| K921575 | Igg Suclass EiaDEW · Traditional | Virotech Diagnostika | 05/28/1992SE |
| K911610 | Elisa Combi-Kit Human Igg SubclassesDEW · Traditional | Janssen Research Foundation | 06/12/1991SE |
| K900943 | Modified Technicon DPA-1(TM) SystemDEW · Traditional | Technicon Instruments Corp. | 04/26/1990SE |
| K893419 | Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)DEW · Traditional | Coulter Immunology | 08/03/1989SE |
| K891385 | Vitek Immunodiagnostic Assay System (Vidas)DEW · Traditional | Vitek Systems, Inc. | 04/18/1989SE |
| K890416 | Spq(Tm) Antibody Reagent Set II for IggDEW · Traditional | Atlantic Antibodies | 02/22/1989SE |
| K882369 | Accraassay Rid KitsDEW · Traditional | Icn Immunobiologicals | 07/12/1988SE |
| K882083 | QM300 Igg Antibody PackDEW · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/08/1988SE |
| K880784 | Wako(Tm) Igg-Ha DirectDEW · Traditional | Wako Chemicals USA, Inc. | 06/06/1988SE |
| K875254 | Gullsorb Igg Inactivation ReagentDEW · Traditional | Gull Laboratories, Inc. | 02/17/1988SE |
| K875356 | Immunoglobulin G & G SubclassesDEW · Traditional | Birmingham | 02/10/1988SE |
| K873870 | Immunoglobulins GDEW · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K872800 | TDX Immunoglobulin G Diagnostic KitDEW · Traditional | Abbott Laboratories | 08/12/1987SE |
| K871352 | Pentavalent Antiserum to Human ImmunoglobulinsDEW · Traditional | Helena Laboratories | 04/22/1987SE |
| K871340 | QM300 Igg Antibody PackDEW · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/22/1987SE |
| K862764 | Tina-Quant(R) IggDEW · Traditional | Boehringer Mannheim Corp. | 09/03/1986SE |
| K861059 | Dako Ita SystemDEW · Traditional | Dako Corp. | 08/25/1986SE |
| K853465 | Gilford Immunoglobulin G ReagentDEW · Traditional | Gilford | 09/16/1985SE |
| K852589 | TDX Immunoglobulin G Diagnostic KitDEW · Traditional | Abbott Laboratories | 07/15/1985SE |
| K851541 | Dart Immunoglobulins Reagent SystemDEW · Traditional | Coulter Electronics, Inc. | 07/15/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | Applications Lab | 03/01/1985SE |
| K842329 | Amer. Histo-Id Sys Primary Igg S7920-11DEW · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 08/02/1984SE |
| K841816 | Optimate Igg TestDEW · Traditional | Miles Laboratories, Inc. | 06/22/1984SE |
| K833402 | Tech. RA-1000SYS-ANALYTES ImmunoglobulinDEW · Traditional | Technicon Instruments Corp. | 01/24/1984SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K832264 | Fitc Goat Anti-Human Igg Y ChainDEW · Traditional | Gelco Diagnostics, Inc. | 10/28/1983SE |
| K831101 | Tia-Igg Reagent & Calibrator SetsDEW · Traditional | Worthington Diagnostic Systems | 04/27/1983SE |
| K830594 | Titan Immuno-FixDEW · Traditional | Helena Laboratories | 03/24/1983SE |
| K821018 | Antihuman Igg Globulin Fitc LabeledDEW · Traditional | Microbiological Research Corp. | 04/29/1982SE |
| K812484 | Dako Pap Kit K505DEW · Traditional | Dako Corp. | 02/10/1982SE |
| K812664 | Aca Immunoglobulin G Analytical TestDEW · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/02/1981SE |
| K812630 | Aca Immunoglobulin G CalibratorDEW · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/29/1981SE |
| K812495 | Immunogl. Frct. of Rabbit Antiser.-AlphaDEW · Traditional | Dako Corp. | 09/23/1981SE |
| K812489 | Immunogl. Frct. of Rabbit Antiser.-IggDEW · Traditional | Dako Corp. | 09/23/1981SE |
| K812453 | Scrippsystem Immunoglobin Rid KitDEW · Traditional | Scripps-Miles, Inc. | 09/23/1981SE |
| K812328 | Scrippsystem Nephelometric Antisera KitDEW · Traditional | Scripps-Miles, Inc. | 09/08/1981SE |
| K810694 | Phadebas Igg Rast TestDEW · Traditional | Pharmacia, Inc. | 07/23/1981SE |
| K811126 | Aim System (for Igg)DEW · Traditional | Icl Scientific | 05/08/1981SE |
| K810056 | Immunology Control SerumDEW · Traditional | Icl Scientific | 02/09/1981SE |
| K802257 | Goat Anti-Human Igg Gamma Chain SpecificDEW · Traditional | Protos Laboratories | 10/31/1980SE |
| K801281 | J.T. Baker Immunoglobulin G NephelometriDEW · Traditional | J.T. Baker Chemical Co. | 06/20/1980SE |
| K800897 | Rid System-Quad Multitest Igg, Iga,Etc.DEW · Traditional | Icl Scientific | 05/08/1980SE |
| K800451 | Gemeni Igg AssayDEW · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/24/1980SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | Diagnostica, Inc. | 03/12/1980SE |
| K800119 | Immunoglobulin G Reagent SystemDEW · Traditional | Calbiochem-Behring Corp. | 02/05/1980SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | Diagnostica, Inc. | 11/27/1979SE |
| K791824 | Antiserum to Human ImmunoglobulinsDEW · Traditional | Icl Scientific | 10/17/1979SE |
| K791403 | Lancer L-Ina Anti-IggDEW · Traditional | Sherwood Medical Co. | 10/17/1979SE |
| K791285 | Anti-Human GlobulinsDEW · Traditional | Diagnostica, Inc. | 10/17/1979SE |
| K790702 | Antiserum, Human, Igg H & L ChainDEW · Traditional | Kent Laboratories, Inc. | 09/04/1979SE |
| K790704 | Antiserum to Human IggDEW · Traditional | Kent Laboratories, Inc. | 04/12/1979SESP |
| K772077 | Radial Immunodiffusion Kit-Immunoglob.GDEW · Traditional | Gelman Instrument Co. | 02/03/1978SE |
| K772252 | Immunoglobulin G Nephel. AssayDEW · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
| K770961 | Goat Antiserum Igg NephelometricDEW · Traditional | Kallestad Laboratories, Inc. | 06/24/1977SE |
| K770669 | Rhodamine-Conjugated AntiserumDEW · Traditional | Kent Laboratories, Inc. | 04/28/1977SE |
| K770668 | Fluorescein Conjugated AntiserumDEW · Traditional | Kent Laboratories, Inc. | 04/28/1977SE |
| K770597 | Dasp TM Anti-RabbitDEW · Traditional | Organon, Inc. | 04/28/1977SE |
| K761224 | Ultra Low Level Immunoglobulin GDEW · Traditional | Intl. Diagnostic Technology | 04/07/1977SE |
| K770484 | Fluor. Conjugated AntiserumDEW · Traditional | Kent Laboratories, Inc. | 03/21/1977SE |
| K760145 | Serum, Igg Goat Anti-Human AcidDEW · Traditional | Oxford Laboratories, Inc. | 07/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0118-2025 Class II | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when…Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU | Beckman Coulter Inc. | 07/31/2024Open, Classified |
| Z-1989-2019 Class II | Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |
| Z-2653-2010 | SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A… | Beckman Coulter Inc. | 06/28/2010Terminated |