Panels › Microbiology › Product code LFX · Class 2
Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation 866.3510
1510(k)s in 12 months (94 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
Top companies in LFX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2025 | K250588 | Access Rubella IgG Beckman Coulter, Inc. | LFX |
| Jun 20, 2025 | K243168 | Alinity i Rubella IgG Abbott Laboratories | LFX |
| Sep 6, 2012 | K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DiaSorin, Inc. | LFX |
| Jan 21, 2011 | K093101 | MAGO 4S Diamedix Corp. | LFX |
| Dec 3, 2010 | K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | LFX |
| Mar 12, 2010 | K092322 | ELECSYS RUBELLA IGM IMMUNOASSAY Roche Diagnostics | LFX |
| Dec 23, 2008 | K080766 | VIDAS RUB IGG bioMerieux, Inc. | LFX |
| Dec 5, 2008 | K072617 | ELECSYS RUBELLA IGG IMMUNOASSAY Roche Diagnostics Corp. | LFX |
| Nov 21, 2008 | K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS DiaSorin, Inc. | LFX |
| Mar 21, 2007 | K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM Zeus Scientific, Inc. | LFX |
| Dec 26, 2006 | K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. | LFX |
| Jun 20, 2003 | K031606 | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY Beckman Coulter, Inc. | LFX |
| Jan 10, 2002 | K012077 | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 Diagnostic Products Corp. | LFX |
| Jul 5, 2001 | K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY Bayer Corp. | LFX |
| Apr 13, 2001 | K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY Bayer Corp. | LFX |
| Aug 21, 2000 | K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM Diamedix Corp. | LFX |
| Feb 10, 2000 | K993291 | COPALIS RUBELLA IGM DiaSorin, Inc. | LFX |
| Jul 20, 1999 | K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LFX |
| May 26, 1999 | K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO Zeus Scientific, Inc. | LFX |
| Jan 28, 1999 | K981729 | IS-RUBELLA IGG TEST SYSTEM Diamedix Corp. | LFX |
| Dec 11, 1998 | K982078 | IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) Diagnostic Products Corp. | LFX |
| Oct 16, 1998 | K982281 | SERAQUEST RUBELLA IGM Quest Intl., Inc. | LFX |
| Jan 2, 1998 | K971304 | QUANTA LITE REBELLA IGG Inova Diagnostics, Inc. | LFX |
| Apr 2, 1997 | K963613 | IMMULITE RUBELLA IGG Diagnostic Products Corp. | LFX |
| Dec 20, 1996 | K952721 | RUBASCAN CARD TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | LFX |
| Oct 24, 1996 | K960367 | INCSTAR RUBELLA IGG ELISA ASSAY Incstar Corp. | LFX |
| Oct 24, 1996 | K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY Incstar Corp. | LFX |
| Sep 24, 1996 | K954045 | AXSYM RUBELLA IGG ANTIBODY ASSAY Abbott Laboratories | LFX |
| Sep 4, 1996 | K961053 | SERAQUEST RUBELLA IGG Quest Intl., Inc. | LFX |
| Jul 16, 1996 | K951541 | IMX RUBELLA IGG Abbott Laboratories | LFX |
| May 14, 1996 | K954318 | ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY Abbott Laboratories | LFX |
| Apr 15, 1996 | K951359 | RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE Bayer Corp. | LFX |
| Apr 9, 1996 | K954687 | ACCESS RUBELLA IGG Bio-Rad Laboratories, Inc. | LFX |
| Aug 15, 1995 | K950227 | RUBELISA (RUBESTAT) Bio-Whittaker, Inc., A Cambrex Co. | LFX |
| Aug 4, 1995 | K941624 | RUBELLA IGG ELISA TEST Gull Laboratories, Inc. | LFX |
| Dec 19, 1994 | K931059 | IMX RUBELLA IGM ANTIBODY ASSAY Abbott Laboratories | LFX |
| Jul 12, 1994 | K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST Princeton Biomedix | LFX |
| Sep 17, 1992 | K922586 | BARTELS RUBELLA IGG EIA Baxter Diagnostics, Inc. | LFX |
| Sep 17, 1992 | K922581 | BARTELS RUBELLA IGM EIA Baxter Diagnostics, Inc. | LFX |
| Aug 27, 1992 | K921573 | RUBELLA IGM Clark Laboratories, Inc. | LFX |
| Apr 22, 1992 | K914028 | RUBELLA IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LFX |
| Mar 23, 1992 | K915870 | OPUS RUBELLA TEST SYSTEM Pb Diagnostics, Inc. | LFX |
| Mar 4, 1992 | K915893 | RUBELLA IGG ELISA TEST Gull Laboratories, Inc. | LFX |
| Dec 27, 1991 | K914420 | ELISA RUBELLA IGM Sclavo, Inc. | LFX |
| Aug 30, 1991 | K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM Wampole Laboratories | LFX |
| Apr 29, 1991 | K911393 | RUBENOSTIKA IGG MICROELISA SYSTEM Organon Teknika Corp. | LFX |
| Dec 4, 1990 | K905079 | ORTHO RUBELLA-M ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFX |
| Dec 4, 1990 | K904084 | RUBELLA IGM ELISA TEST Gull Laboratories, Inc. | LFX |
| Dec 4, 1990 | K903308 | TRANSTAT-CMV(TM) Ab Sangtec Medical | LFX |
| Sep 5, 1990 | K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST Disease Detection International, Inc. | LFX |
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