Atlas FDA

LFX

94 FDA 510(k) clearances · Product code

140 daysmedian time to decision
385 days90th percentile
94clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Rubella
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3510
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 10 · 2018: 24 · 2019: 16 · 2020: 21 · 2021: 13 · 2022: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Rubella IgG (K250588)Beckman Coulter, Inc.2025-11-17
Alinity i Rubella IgG (K243168)Abbott Laboratories2025-06-20
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397)DiaSorin, Inc.2012-09-06
MAGO 4S (K093101)Diamedix Corp.2011-01-21
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587)Bio-Rad Laboratories2010-12-03
ELECSYS RUBELLA IGM IMMUNOASSAY (K092322)Roche Diagnostics2010-03-12
VIDAS RUB IGG (K080766)bioMerieux, Inc.2008-12-23
ELECSYS RUBELLA IGG IMMUNOASSAY (K072617)Roche Diagnostics Corp.2008-12-05
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (K073390)DiaSorin, Inc.2008-11-21
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (K063186)Zeus Scientific, Inc.2007-03-21
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143)Ortho-Clinical Diagnostics, Inc.2006-12-26
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606)Beckman Coulter, Inc.2003-06-20
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 (K012077)Diagnostic Products Corp.2002-01-10
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY (K010668)Bayer Corp.2001-07-05
ADVIA CENTAUR RUBELLA IGG ASSAY (K003412)Bayer Corp.2001-04-13
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM (K001875)Diamedix Corp.2000-08-21
COPALIS RUBELLA IGM (K993291)DiaSorin, Inc.2000-02-10
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM (K984180)Zeus Scientific, Inc.1999-07-20
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983805)Zeus Scientific, Inc.1999-05-26
IS-RUBELLA IGG TEST SYSTEM (K981729)Diamedix Corp.1999-01-28
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) (K982078)Diagnostic Products Corp.1998-12-11
SERAQUEST RUBELLA IGM (K982281)Quest Intl., Inc.1998-10-16
QUANTA LITE REBELLA IGG (K971304)Inova Diagnostics, Inc.1998-01-02
IMMULITE RUBELLA IGG (K963613)Diagnostic Products Corp.1997-04-02
RUBASCAN CARD TEST (K952721)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-12-20
INCSTAR RUBELLA IGG ELISA ASSAY (K960367)Incstar Corp.1996-10-24
INCSTAR RUBELLA IGG FAST ELISA ASSAY (K960358)Incstar Corp.1996-10-24
AXSYM RUBELLA IGG ANTIBODY ASSAY (K954045)Abbott Laboratories1996-09-24
SERAQUEST RUBELLA IGG (K961053)Quest Intl., Inc.1996-09-04
IMX RUBELLA IGG (K951541)Abbott Laboratories1996-07-16
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY (K954318)Abbott Laboratories1996-05-14
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE (K951359)Bayer Corp.1996-04-15
ACCESS RUBELLA IGG (K954687)Bio-Rad Laboratories, Inc.1996-04-09
RUBELISA (RUBESTAT) (K950227)Bio-Whittaker, Inc., A Cambrex Co.1995-08-15
RUBELLA IGG ELISA TEST (K941624)Gull Laboratories, Inc.1995-08-04
IMX RUBELLA IGM ANTIBODY ASSAY (K931059)Abbott Laboratories1994-12-19
BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (K925355)Princeton Biomedix1994-07-12
BARTELS RUBELLA IGG EIA (K922586)Baxter Diagnostics, Inc.1992-09-17
BARTELS RUBELLA IGM EIA (K922581)Baxter Diagnostics, Inc.1992-09-17
RUBELLA IGM (K921573)Clark Laboratories, Inc.1992-08-27
RUBELLA IGM ELISA TEST SYSTEM (K914028)Zeus Scientific, Inc.1992-04-22
OPUS RUBELLA TEST SYSTEM (K915870)Pb Diagnostics, Inc.1992-03-23
RUBELLA IGG ELISA TEST (K915893)Gull Laboratories, Inc.1992-03-04
ELISA RUBELLA IGM (K914420)Sclavo, Inc.1991-12-27
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (K911444)Wampole Laboratories1991-08-30
RUBENOSTIKA IGG MICROELISA SYSTEM (K911393)Organon Teknika Corp.1991-04-29
RUBELLA IGM ELISA TEST (K904084)Gull Laboratories, Inc.1990-12-04
ORTHO RUBELLA-M ANTIBODY ELISA TEST (K905079)Ortho Diagnostic Systems, Inc.1990-12-04
TRANSTAT-CMV(TM) (K903308)Ab Sangtec Medical1990-12-04
MODIFICATION OF SEROCARD RUBELLA IGG TEST (K902571)Disease Detection International, Inc.1990-09-05
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) (K902925)Vitek Systems, Inc.1990-08-09
RUBELLA IGG (K902793)Pharmacia Diagnostics, Inc.1990-07-31
RUBELLA IGG ELISA TEST (K901635)Gull Laboratories, Inc.1990-06-28
ORTHO* RUBELLA-G ANTIBODY ELISA TEST (K896479)Ortho Diagnostic Systems, Inc.1989-12-29
PLATELIA RUBELLA IGG KIT (K894946)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-21
IMMUNODOT RUBELLA TEST (K894546)General Biometrics, Inc.1989-10-16
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST (K892202)Gull Laboratories, Inc.1989-09-13
BIOTROL RUB-E.I.A. TEST G (K894544)Biotrol, USA, Inc.1989-08-30
CAPTIA(R) RUBELLA-G (K883924)Mercia Diagnostics , Ltd.1989-08-15
CAPTIA(R) RUBELLA-M (K885300)Mercia Diagnostics , Ltd.1989-08-15
RUBELLA ELISA TEST SYSTEM (K891783)Zeus Scientific, Inc.1989-08-03
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY (K885295)Abbott Laboratories1989-06-23
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY (K885297)Abbott Laboratories1989-06-23
RUBELLA-CUBE(TM) (K892051)Difco Laboratories, Inc.1989-06-08
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (K884247)Disease Detection International, Inc.1989-04-10
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (K890091)Labsystems, Inc.1989-02-03
IMMUNODOT TORCH TEST RUBELLA (K884898)General Biometrics, Inc.1989-02-03
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY (K884617)Ortho Diagnostic Systems, Inc.1989-02-02
IMMUNODOT RUBELLA TEST (K885082)General Biometrics, Inc.1989-02-02
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM (K882999)Organon Teknika Corp.1989-01-31
FIAGEN RUBELLA IGG (K883182)Cyberfluor, Inc.1988-10-31
RUBELLA IGM MICROASSAY (K883778)Diamedix Corp.1988-10-25
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 (K882475)Amersham Corp.1988-10-06
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (K881243)Labsystems, Inc.1988-04-04
THE DDI SERODOT RUBELLA IGG TEST KIT (K875368)Disease Detection International, Inc.1988-03-23
MODIFICATION RUBELLA IGM EIA TEST KIT (K873780)Labsystems, Inc.1987-10-15
VIRGO(TM) RUBELLA IGG ELISA (K873088)Electro-Nucleonics Laboratories, Inc.1987-09-09
CHROMOTITRE E.I.A. RUBELLA IGG (K872071)Ismunit Istituto Immunologico Intaliano1987-08-24
RUBELLA MICROASSAY (K864602)Diamedix Corp.1987-04-14
CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY (K864315)Cytotech, Inc.1987-02-02
RUBELLA IGM EIA TEST KIT (K862431)Labsystems, Inc.1986-08-08
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 (K860145)Clinical Sciences, Inc.1986-07-14
RUBELLA IGG EIA TEST KIT (K853696)Labsystems, Inc.1986-06-17
MUREX SUDS RUBELLA (K861282)Murex Corp.1986-06-13
CORDOT R (K854618)Cordis Corp.1986-05-01
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT (K853069)Hybritech, Inc.1986-01-01
RUBELLA IGG ANTIBODY ELISA TEST SYS (K841200)Ortho Diagnostic Systems, Inc.1984-05-21
ORTHO RUBELLA ELISA TEST SYSTEM (K822342)Ortho Diagnostic Systems, Inc.1983-03-17
RUBELLA RQ BIO-ENZABEAD KIT (K821804)Litton Bionetics1982-09-14
ENZYGNOST TM RUBELLA IGM (K813493)Calbiochem-Behring Corp.1982-03-04
EIA RUBELLA (K812787)Gilford1981-11-27
RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (K803133)Microbiological Research Corp.1981-01-29
RUBELLA VIRUS SEROLOGICAL REAGENTS (K803175)Microbiological Research Corp.1981-01-29
ROTAZYME (K791746)Abbott Laboratories1979-11-16

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