Enzyme Linked Immunoabsorbent Assay, Rubella
FDA product code LFX · Class II (moderate risk) · 21 CFR 866.3510 · Microbiology
94510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Abbott Laboratories 8
- Zeus Scientific, Inc. 5
- Ortho Diagnostic Systems, Inc. 5
- Labsystems, Inc. 5
- Diamedix Corp. 5
- Gull Laboratories, Inc. 5
- Diagnostic Products Corp. 3
- Bayer Corp. 3
- General Biometrics, Inc. 3
- Disease Detection International, Inc. 3
- DiaSorin, Inc. 3
- Microbiological Research Corp. 2
- Organon Teknika Corp. 2
- Mercia Diagnostics , Ltd. 2
- Quest Intl., Inc. 2
- Roche Diagnostics Corp. 2
- Bio-Rad Laboratories, Inc. 2
- Incstar Corp. 2
- Baxter Diagnostics, Inc. 2
- Beckman Coulter Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
| K063143 | Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and CalibratorsLFX · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/26/2006SE |
| K031606 | Access Immunoassay System Rubella Igg AssayLFX · Special | Beckman Coulter, Inc. | 06/20/2003SE |
| K012077 | Immulite Rubella IGM,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2, L2KRM6LFX · Traditional | Diagnostic Products Corp. | 01/10/2002SE |
| K010668 | Bayer Diagnostics Advia Centaur Rubella Igm AssayLFX · Traditional | Bayer Corp. | 07/05/2001SE |
| K003412 | Advia Centaur Rubella Igg AssayLFX · Traditional | Bayer Corp. | 04/13/2001SE |
| K001875 | Diamedix Is-Rubella Igm Capture Test SystemLFX · Traditional | Diamedix Corp. | 08/21/2000SE |
| K993291 | Copalis Rubella IgmLFX · Traditional | DiaSorin, Inc. | 02/10/2000SE |
| K984180 | The Aptus (Automated) Application of the Rubella Igm Elisa Test SystemLFX · Traditional | Zeus Scientific, Inc. | 07/20/1999SE |
| K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked…LFX · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K981729 | Is-Rubella Igg Test SystemLFX · Traditional | Diamedix Corp. | 01/28/1999SE |
| K982078 | Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests)LFX · Traditional | Diagnostic Products Corp. | 12/11/1998SE |
| K982281 | Seraquest Rubella IgmLFX · Traditional | Quest Intl., Inc. | 10/16/1998SE |
| K971304 | Quanta Lite Rebella IggLFX · Traditional | Inova Diagnostics, Inc. | 01/02/1998SE |
| K963613 | Immulite Rubella IggLFX · Traditional | Diagnostic Products Corp. | 04/02/1997SE |
| K952721 | Rubascan Card TestLFX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/20/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | Incstar Corp. | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | Incstar Corp. | 10/24/1996SE |
| K954045 | Axsym Rubella Igg Antibody AssayLFX · Traditional | Abbott Laboratories | 09/24/1996SE |
| K961053 | Seraquest Rubella IggLFX · Traditional | Quest Intl., Inc. | 09/04/1996SE |
| K951541 | Imx Rubella IggLFX · Traditional | Abbott Laboratories | 07/16/1996SE |
| K954318 | Abbott Axsym Rubella Igm Antibody AssayLFX · Traditional | Abbott Laboratories | 05/14/1996SE |
| K951359 | Rubella Igg Assay for the Technicon Immuno 1 System In-Vitro Diagnostic DeviceLFX · Traditional | Bayer Corp. | 04/15/1996SE |
| K954687 | Access Rubella IggLFX · Traditional | Bio-Rad Laboratories, Inc. | 04/09/1996SE |
| K950227 | Rubelisa (Rubestat)LFX · Traditional | Bio-Whittaker, Inc., A Cambrex Co. | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | Gull Laboratories, Inc. | 08/04/1995SE |
| K931059 | Imx Rubella Igm Antibody AssayLFX · Traditional | Abbott Laboratories | 12/19/1994SE |
| K925355 | Biosign(Tm_ Rubella - Rubella Antibody TestLFX · Traditional | Princeton Biomedix | 07/12/1994SE |
| K922586 | Bartels Rubella Igg EiaLFX · Traditional | Baxter Diagnostics, Inc. | 09/17/1992SE |
| K922581 | Bartels Rubella Igm EiaLFX · Traditional | Baxter Diagnostics, Inc. | 09/17/1992SE |
| K921573 | Rubella IgmLFX · Traditional | Clark Laboratories, Inc. | 08/27/1992SE |
| K914028 | Rubella Igm Elisa Test SystemLFX · Traditional | Zeus Scientific, Inc. | 04/22/1992SE |
| K915870 | Opus Rubella Test SystemLFX · Traditional | Pb Diagnostics, Inc. | 03/23/1992SE |
| K915893 | Rubella Igg Elisa TestLFX · Traditional | Gull Laboratories, Inc. | 03/04/1992SE |
| K914420 | Elisa Rubella IgmLFX · Traditional | Sclavo, Inc. | 12/27/1991SE |
| K911444 | Rubella Virus Immunological Test SystemLFX · Traditional | Wampole Laboratories | 08/30/1991SE |
| K911393 | Rubenostika Igg Microelisa SystemLFX · Traditional | Organon Teknika Corp. | 04/29/1991SE |
| K905079 | Ortho Rubella-M Antibody Elisa TestLFX · Traditional | Ortho Diagnostic Systems, Inc. | 12/04/1990SE |
| K904084 | Rubella Igm Elisa TestLFX · Traditional | Gull Laboratories, Inc. | 12/04/1990SE |
| K903308 | Transtat-Cmv(Tm)LFX · Traditional | Ab Sangtec Medical | 12/04/1990SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | Disease Detection International, Inc. | 09/05/1990SE |
| K902925 | Vitek Immunodiagnostic Assay System (Vidas) (RBG)LFX · Traditional | Vitek Systems, Inc. | 08/09/1990SE |
| K902793 | Rubella IggLFX · Traditional | Pharmacia Diagnostics, Inc. | 07/31/1990SE |
| K901635 | Rubella Igg Elisa TestLFX · Traditional | Gull Laboratories, Inc. | 06/28/1990SE |
| K896479 | Ortho* Rubella-G Antibody Elisa TestLFX · Traditional | Ortho Diagnostic Systems, Inc. | 12/29/1989SE |
| K894946 | Platelia Rubella Igg KitLFX · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 12/21/1989SE |
| K894546 | Immunodot Rubella TestLFX · Traditional | General Biometrics, Inc. | 10/16/1989SE |
| K892202 | Detectadot(Tm) System 2000 Rubella Igg TestLFX · Traditional | Gull Laboratories, Inc. | 09/13/1989SE |
| K894544 | Biotrol Rub-E.I.A. Test GLFX · Traditional | Biotrol, USA, Inc. | 08/30/1989SE |
| K885300 | Captia(R) Rubella-MLFX · Traditional | Mercia Diagnostics , Ltd. | 08/15/1989SE |
| K883924 | Captia(R) Rubella-GLFX · Traditional | Mercia Diagnostics , Ltd. | 08/15/1989SE |
| K891783 | Rubella Elisa Test SystemLFX · Traditional | Zeus Scientific, Inc. | 08/03/1989SE |
| K885297 | Imx Rubella Igg, Microparticle Enzyme ImmunoassayLFX · Traditional | Abbott Laboratories | 06/23/1989SE |
| K885295 | Imx Rubella Igm, Micropart. Enzyme ImmunoassayLFX · Traditional | Abbott Laboratories | 06/23/1989SE |
| K892051 | Rubella-Cube(Tm)LFX · Traditional | Difco Laboratories, Inc. | 06/08/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | Disease Detection International, Inc. | 04/10/1989SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | Labsystems, Inc. | 02/03/1989SE |
| K884898 | Immunodot Torch Test RubellaLFX · Traditional | General Biometrics, Inc. | 02/03/1989SE |
| K885082 | Immunodot Rubella TestLFX · Traditional | General Biometrics, Inc. | 02/02/1989SE |
| K884617 | Ortho Result Plus/Rubella Rapid Color. ImmunoassayLFX · Traditional | Ortho Diagnostic Systems, Inc. | 02/02/1989SE |
| K882999 | Rubenostika(Tm) Igm Microelisa SystemLFX · Traditional | Organon Teknika Corp. | 01/31/1989SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | Cyberfluor, Inc. | 10/31/1988SE |
| K883778 | Rubella Igm MicroassayLFX · Traditional | Diamedix Corp. | 10/25/1988SE |
| K882475 | Amerlite Rubella Antibody Assay, LAN.0200/2200LFX · Traditional | Amersham Corp. | 10/06/1988SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | Labsystems, Inc. | 04/04/1988SE |
| K875368 | The Ddi Serodot Rubella Igg Test KitLFX · Traditional | Disease Detection International, Inc. | 03/23/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | Labsystems, Inc. | 10/15/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/09/1987SE |
| K872071 | Chromotitre E.I.A. Rubella IggLFX · Traditional | Ismunit Istituto Immunologico Intaliano | 08/24/1987SE |
| K864602 | Rubella MicroassayLFX · Traditional | Diamedix Corp. | 04/14/1987SE |
| K864315 | Cytotech Rubella Igg Enzyme ImmunoassayLFX · Traditional | Cytotech, Inc. | 02/02/1987SE |
| K862431 | Rubella Igm Eia Test KitLFX · Traditional | Labsystems, Inc. | 08/08/1986SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | Clinical Sciences, Inc. | 07/14/1986SE |
| K853696 | Rubella Igg Eia Test KitLFX · Traditional | Labsystems, Inc. | 06/17/1986SE |
| K861282 | Murex Suds RubellaLFX · Traditional | Murex Corp. | 06/13/1986SE |
| K854618 | Cordot RLFX · Traditional | Cordis Corp. | 05/01/1986SE |
| K853069 | Tandem Icon Rubella Igg Immunoenzymetric Assay KitLFX · Traditional | Hybritech, Inc. | 01/01/1986SE |
| K841200 | Rubella Igg Antibody Elisa Test SysLFX · Traditional | Ortho Diagnostic Systems, Inc. | 05/21/1984SE |
| K822342 | Ortho Rubella Elisa Test SystemLFX · Traditional | Ortho Diagnostic Systems, Inc. | 03/17/1983SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | Litton Bionetics | 09/14/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | Calbiochem-Behring Corp. | 03/04/1982SE |
| K812787 | Eia RubellaLFX · Traditional | Gilford | 11/27/1981SE |
| K803175 | Rubella Virus Serological ReagentsLFX · Traditional | Microbiological Research Corp. | 01/29/1981SE |
| K803133 | Rubella Virus Serological Reagent RubelLFX · Traditional | Microbiological Research Corp. | 01/29/1981SE |
| K791746 | RotazymeLFX · Traditional | Abbott Laboratories | 11/16/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0432-2022 Class II | VIDAS RUB IgG (RBG), REF 30226bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-0082-2017 Class II | SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US:…Siemens received multiple customer complaints indicating an increase in false positive and indeterminate… | Siemens Healthcare Diagnostics, Inc. | 08/24/2016Terminated |
| Z-0081-2017 Class II | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1…Siemens received multiple customer complaints indicating an increase in false positive and indeterminate… | Siemens Healthcare Diagnostics, Inc. | 08/24/2016Terminated |
| Z-0203-2012 | EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II…Internal testing has shown that the indicated kits produce false negative results when tested with some… | Meridian Bioscience Inc | 10/10/2011Terminated |
| Z-1636-2011 | Rubella IgG ELISA kit ; Rubella IgM ELISA kit BioCheck, Foster City, CA 9440.…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |
| Z-2201-2011 | Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF…The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of… | Bio-Rad Laboratories | 07/19/2010Terminated |
| Z-0922-2010 | DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951…DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two… | Diasorin Inc. | 12/16/2009Terminated |
| Z-1066-2010 | IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for… | Siemens Healthcare Diagnostics Inc. | 10/21/2009Terminated |
| Z-1033-2010 | IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for… | Siemens Healthcare Diagnostics Inc. | 10/21/2009Terminated |
| Z-0908-2010 | Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1…Elevated optical density (OD) values with the kit Negative Control. | Bio-Rad Laboratories | 08/20/2008Terminated |
| Z-2175-2008 | AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20…An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes… | Abbott Laboratories | 06/02/2008Terminated |
| Z-1032-2007 | AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-1025-2007 | AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |