Enzyme Linked Immunoabsorbent Assay, Rubella

FDA product code LFX · 94 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.3510
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-11-16 – 2025-11-17

LFX 2025-11-17

Access Rubella IgG

Applicant Beckman Coulter, Inc.

K number K250588

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LFX 2025-06-20

Alinity i Rubella IgG

Applicant Abbott Laboratories

K number K243168

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LFX 2012-09-06

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

Applicant DiaSorin, Inc.

K number K122397

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LFX 2011-01-21

MAGO 4S

Applicant Diamedix Corp.

K number K093101

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LFX 2010-12-03

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

Applicant Bio-Rad Laboratories

K number K092587

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LFX 2010-03-12

ELECSYS RUBELLA IGM IMMUNOASSAY

Applicant Roche Diagnostics

K number K092322

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LFX 2008-12-23

VIDAS RUB IGG

Applicant bioMerieux, Inc.

K number K080766

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LFX 2008-12-05

ELECSYS RUBELLA IGG IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K072617

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LFX 2008-11-21

DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS

Applicant DiaSorin, Inc.

K number K073390

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LFX 2007-03-21

ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K063186

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LFX 2006-12-26

VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K063143

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LFX 2003-06-20

ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

Applicant Beckman Coulter, Inc.

K number K031606

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LFX 2002-01-10

IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6

Applicant Diagnostic Products Corp.

K number K012077

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LFX 2001-07-05

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY

Applicant Bayer Corp.

K number K010668

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LFX 2001-04-13

ADVIA CENTAUR RUBELLA IGG ASSAY

Applicant Bayer Corp.

K number K003412

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LFX 2000-08-21

DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM

Applicant Diamedix Corp.

K number K001875

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LFX 2000-02-10

COPALIS RUBELLA IGM

Applicant DiaSorin, Inc.

K number K993291

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LFX 1999-07-20

THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K984180

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LFX 1999-05-26

THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO

Applicant Zeus Scientific, Inc.

K number K983805

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LFX 1999-01-28

IS-RUBELLA IGG TEST SYSTEM

Applicant Diamedix Corp.

K number K981729

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LFX 1998-12-11

IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)

Applicant Diagnostic Products Corp.

K number K982078

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LFX 1998-10-16

SERAQUEST RUBELLA IGM

Applicant Quest Intl., Inc.

K number K982281

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LFX 1998-01-02

QUANTA LITE REBELLA IGG

Applicant Inova Diagnostics, Inc.

K number K971304

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LFX 1997-04-02

IMMULITE RUBELLA IGG

Applicant Diagnostic Products Corp.

K number K963613

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LFX 1996-12-20

RUBASCAN CARD TEST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K952721

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LFX 1996-10-24

INCSTAR RUBELLA IGG ELISA ASSAY

Applicant Incstar Corp.

K number K960367

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LFX 1996-10-24

INCSTAR RUBELLA IGG FAST ELISA ASSAY

Applicant Incstar Corp.

K number K960358

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LFX 1996-09-24

AXSYM RUBELLA IGG ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K954045

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LFX 1996-09-04

SERAQUEST RUBELLA IGG

Applicant Quest Intl., Inc.

K number K961053

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LFX 1996-07-16

IMX RUBELLA IGG

Applicant Abbott Laboratories

K number K951541

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LFX 1996-05-14

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K954318

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LFX 1996-04-15

RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE

Applicant Bayer Corp.

K number K951359

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LFX 1996-04-09

ACCESS RUBELLA IGG

Applicant Bio-Rad Laboratories, Inc.

K number K954687

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LFX 1995-08-15

RUBELISA (RUBESTAT)

Applicant Bio-Whittaker, Inc., A Cambrex Co.

K number K950227

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LFX 1995-08-04

RUBELLA IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K941624

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LFX 1994-12-19

IMX RUBELLA IGM ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K931059

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LFX 1994-07-12

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST

Applicant Princeton Biomedix

K number K925355

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LFX 1992-09-17

BARTELS RUBELLA IGG EIA

Applicant Baxter Diagnostics, Inc.

K number K922586

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LFX 1992-09-17

BARTELS RUBELLA IGM EIA

Applicant Baxter Diagnostics, Inc.

K number K922581

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LFX 1992-08-27

RUBELLA IGM

Applicant Clark Laboratories, Inc.

K number K921573

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LFX 1992-04-22

RUBELLA IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K914028

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LFX 1992-03-23

OPUS RUBELLA TEST SYSTEM

Applicant Pb Diagnostics, Inc.

K number K915870

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LFX 1992-03-04

RUBELLA IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K915893

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LFX 1991-12-27

ELISA RUBELLA IGM

Applicant Sclavo, Inc.

K number K914420

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LFX 1991-08-30

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM

Applicant Wampole Laboratories

K number K911444

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LFX 1991-04-29

RUBENOSTIKA IGG MICROELISA SYSTEM

Applicant Organon Teknika Corp.

K number K911393

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LFX 1990-12-04

ORTHO RUBELLA-M ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K905079

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LFX 1990-12-04

RUBELLA IGM ELISA TEST

Applicant Gull Laboratories, Inc.

K number K904084

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LFX 1990-12-04

TRANSTAT-CMV(TM)

Applicant Ab Sangtec Medical

K number K903308

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LFX 1990-09-05

MODIFICATION OF SEROCARD RUBELLA IGG TEST

Applicant Disease Detection International, Inc.

K number K902571

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LFX 1990-08-09

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)

Applicant Vitek Systems, Inc.

K number K902925

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LFX 1990-07-31

RUBELLA IGG

Applicant Pharmacia Diagnostics, Inc.

K number K902793

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LFX 1990-06-28

RUBELLA IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K901635

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LFX 1989-12-29

ORTHO* RUBELLA-G ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K896479

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LFX 1989-12-21

PLATELIA RUBELLA IGG KIT

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K894946

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LFX 1989-10-16

IMMUNODOT RUBELLA TEST

Applicant General Biometrics, Inc.

K number K894546

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LFX 1989-09-13

DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST

Applicant Gull Laboratories, Inc.

K number K892202

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LFX 1989-08-30

BIOTROL RUB-E.I.A. TEST G

Applicant Biotrol, USA, Inc.

K number K894544

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LFX 1989-08-15

CAPTIA(R) RUBELLA-M

Applicant Mercia Diagnostics , Ltd.

K number K885300

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LFX 1989-08-15

CAPTIA(R) RUBELLA-G

Applicant Mercia Diagnostics , Ltd.

K number K883924

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LFX 1989-08-03

RUBELLA ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K891783

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LFX 1989-06-23

IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY

Applicant Abbott Laboratories

K number K885297

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LFX 1989-06-23

IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY

Applicant Abbott Laboratories

K number K885295

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LFX 1989-06-08

RUBELLA-CUBE(TM)

Applicant Difco Laboratories, Inc.

K number K892051

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LFX 1989-04-10

MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K884247

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LFX 1989-02-03

MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT

Applicant Labsystems, Inc.

K number K890091

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LFX 1989-02-03

IMMUNODOT TORCH TEST RUBELLA

Applicant General Biometrics, Inc.

K number K884898

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LFX 1989-02-02

IMMUNODOT RUBELLA TEST

Applicant General Biometrics, Inc.

K number K885082

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LFX 1989-02-02

ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY

Applicant Ortho Diagnostic Systems, Inc.

K number K884617

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LFX 1989-01-31

RUBENOSTIKA(TM) IGM MICROELISA SYSTEM

Applicant Organon Teknika Corp.

K number K882999

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LFX 1988-10-31

FIAGEN RUBELLA IGG

Applicant Cyberfluor, Inc.

K number K883182

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LFX 1988-10-25

RUBELLA IGM MICROASSAY

Applicant Diamedix Corp.

K number K883778

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LFX 1988-10-06

AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200

Applicant Amersham Corp.

K number K882475

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LFX 1988-04-04

RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201

Applicant Labsystems, Inc.

K number K881243

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LFX 1988-03-23

THE DDI SERODOT RUBELLA IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K875368

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LFX 1987-10-15

MODIFICATION RUBELLA IGM EIA TEST KIT

Applicant Labsystems, Inc.

K number K873780

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LFX 1987-09-09

VIRGO(TM) RUBELLA IGG ELISA

Applicant Electro-Nucleonics Laboratories, Inc.

K number K873088

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LFX 1987-08-24

CHROMOTITRE E.I.A. RUBELLA IGG

Applicant Ismunit Istituto Immunologico Intaliano

K number K872071

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LFX 1987-04-14

RUBELLA MICROASSAY

Applicant Diamedix Corp.

K number K864602

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LFX 1987-02-02

CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY

Applicant Cytotech, Inc.

K number K864315

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LFX 1986-08-08

RUBELLA IGM EIA TEST KIT

Applicant Labsystems, Inc.

K number K862431

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LFX 1986-07-14

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540

Applicant Clinical Sciences, Inc.

K number K860145

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LFX 1986-06-17

RUBELLA IGG EIA TEST KIT

Applicant Labsystems, Inc.

K number K853696

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LFX 1986-06-13

MUREX SUDS RUBELLA

Applicant Murex Corp.

K number K861282

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LFX 1986-05-01

CORDOT R

Applicant Cordis Corp.

K number K854618

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LFX 1986-01-01

TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K853069

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LFX 1984-05-21

RUBELLA IGG ANTIBODY ELISA TEST SYS

Applicant Ortho Diagnostic Systems, Inc.

K number K841200

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LFX 1983-03-17

ORTHO RUBELLA ELISA TEST SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K822342

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LFX 1982-09-14

RUBELLA RQ BIO-ENZABEAD KIT

Applicant Litton Bionetics

K number K821804

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LFX 1982-03-04

ENZYGNOST TM RUBELLA IGM

Applicant Calbiochem-Behring Corp.

K number K813493

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LFX 1981-11-27

EIA RUBELLA

Applicant Gilford

K number K812787

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LFX 1981-01-29

RUBELLA VIRUS SEROLOGICAL REAGENTS

Applicant Microbiological Research Corp.

K number K803175

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LFX 1981-01-29

RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL

Applicant Microbiological Research Corp.

K number K803133

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LFX 1979-11-16

ROTAZYME

Applicant Abbott Laboratories

K number K791746

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