Product code LFX
- Device name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3510
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | 2025-11-17 |
| K243168 | Alinity i Rubella IgG | Abbott Laboratories | 2025-06-20 |
| K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | DiaSorin, Inc. | 2012-09-06 |
| K093101 | MAGO 4S | Diamedix Corp. | 2011-01-21 |
| K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2010-12-03 |
| K092322 | ELECSYS RUBELLA IGM IMMUNOASSAY | Roche Diagnostics | 2010-03-12 |
| K080766 | VIDAS RUB IGG | bioMerieux, Inc. | 2008-12-23 |
| K072617 | ELECSYS RUBELLA IGG IMMUNOASSAY | Roche Diagnostics Corp. | 2008-12-05 |
| K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS | DiaSorin, Inc. | 2008-11-21 |
| K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM | Zeus Scientific, Inc. | 2007-03-21 |
| K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 |
| K031606 | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY | Beckman Coulter, Inc. | 2003-06-20 |
| K012077 | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 | Diagnostic Products Corp. | 2002-01-10 |
| K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY | Bayer Corp. | 2001-07-05 |
| K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY | Bayer Corp. | 2001-04-13 |
| K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-08-21 |
| K993291 | COPALIS RUBELLA IGM | DiaSorin, Inc. | 2000-02-10 |
| K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-07-20 |
| K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | Zeus Scientific, Inc. | 1999-05-26 |
| K981729 | IS-RUBELLA IGG TEST SYSTEM | Diamedix Corp. | 1999-01-28 |
| K982078 | IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) | Diagnostic Products Corp. | 1998-12-11 |
| K982281 | SERAQUEST RUBELLA IGM | Quest Intl., Inc. | 1998-10-16 |
| K971304 | QUANTA LITE REBELLA IGG | Inova Diagnostics, Inc. | 1998-01-02 |
| K963613 | IMMULITE RUBELLA IGG | Diagnostic Products Corp. | 1997-04-02 |
| K952721 | RUBASCAN CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996-12-20 |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | Incstar Corp. | 1996-10-24 |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | Incstar Corp. | 1996-10-24 |
| K954045 | AXSYM RUBELLA IGG ANTIBODY ASSAY | Abbott Laboratories | 1996-09-24 |
| K961053 | SERAQUEST RUBELLA IGG | Quest Intl., Inc. | 1996-09-04 |
| K951541 | IMX RUBELLA IGG | Abbott Laboratories | 1996-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740168780 | Alinity | Abbott Ireland Diagnostics | 2025-12-11 |
| 07613336218440 | Elecsys Rubella IgM | Roche Diagnostics GmbH | 2024-10-24 |
| 00816870024219 | Rubella IgM AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024202 | Rubella IgM AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024172 | Rubella IgG AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024165 | Rubella IgG AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00850049545693 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| 00850049545686 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| B3507203600 | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-07-27 |
| 05391516746878 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746533 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746526 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746519 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746786 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 05391516746748 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 04015630940257 | Elecsys Rubella IgM | Roche Diagnostics GmbH | 2017-05-10 |
| 04015630940240 | Elecsys Rubella IgG | Roche Diagnostics GmbH | 2017-04-21 |
| 08056771100571 | LIAISON® Rubella IgG | DIASORIN SPA | 2016-09-24 |
| 10859035006245 | Alere Rubella-plus® | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10743816001034 | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001027 | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 04015630939275 | Elecsys Rubella IgM Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630939251 | Elecsys Rubella IgG Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865003186 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865003179 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 15099590624873 | Access Rubella IgG QC | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590624880 | Access Rubella IgG Calibrators | Beckman Coulter, Inc. | 2016-09-09 |
| 03573026138585 | VIDAS® RUB IgG | BIOMERIEUX SA | 2016-08-31 |
| 10758750004997 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750004546 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |