Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

FDA product code LGD · 105 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.3780
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1982-01-26 – 2025-03-28

LGD 2025-03-28

Access Toxo IgG

Applicant Beckman Coulter, Inc.

K number K242022

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LGD 2024-10-11

Access Toxo IgM II

Applicant Beckman Coulter, Inc.

K number K242095

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LGD 2024-08-30

Alinity i Toxo IgM

Applicant Abbott Laboratories

K number K233932

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LGD 2022-05-19

ARCHITECT Toxo IgG

Applicant Abbott Laboratories

K number K210596

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LGD 2017-06-23

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

Applicant Roche Diagnostics

K number K162678

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LGD 2013-08-28

LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II

Applicant DiaSorin, Inc.

K number K132234

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LGD 2013-08-09

LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II

Applicant DiaSorin, Inc.

K number K131441

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LGD 2011-05-18

VIDAS TOXO IGG AVIDITY

Applicant bioMerieux, Inc.

K number K101946

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LGD 2011-05-04

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K102681

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LGD 2009-07-01

PLATELIA TOXO IGM KIT MODEL 26211

Applicant Bio-Rad Laboratories

K number K090847

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LGD 2008-06-09

ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG

Applicant Roche Diagnostics Corp.

K number K073501

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LGD 2008-05-23

ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC

Applicant Beckman Coulter, Inc.

K number K080869

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LGD 2006-02-08

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

Applicant Diasorin S.P.A

K number K052499

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LGD 2003-08-08

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY

Applicant Beckman Coulter, Inc.

K number K032162

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LGD 2003-06-02

ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

Applicant Beckman Coulter, Inc.

K number K031506

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LGD 2002-09-30

BIO-RAD PLATELIA TOXO IGG TMB

Applicant Bio-Rad

K number K013839

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LGD 2002-09-30

BIO-RAD PLATELIA TOXO IGM TMB

Applicant Bio-Rad

K number K013837

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LGD 2002-01-10

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6

Applicant Diagnostic Products Corp.

K number K012075

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LGD 2001-12-27

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY

Applicant Bayer Diagnostics Corp.

K number K012183

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LGD 2001-08-20

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

Applicant Bayer Corp.

K number K010755

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LGD 2001-06-13

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

Applicant Beckman Coulter, Inc.

K number K003259

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LGD 2000-08-31

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

Applicant Beckman Coulter, Inc.

K number K002453

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LGD 2000-07-07

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

Applicant Diamedix Corp.

K number K001707

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LGD 2000-05-22

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210

Applicant bioMerieux, Inc.

K number K993319

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LGD 1999-01-22

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

Applicant Zeus Scientific, Inc.

K number K984317

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LGD 1999-01-19

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

Applicant Zeus Scientific, Inc.

K number K984170

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LGD 1998-09-17

ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469

Applicant Beckman Instruments, Inc.

K number K973448

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LGD 1998-08-21

IS-TOXOPLASMA IGG TEST SYSTEM

Applicant Diamedix Corp.

K number K981498

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LGD 1997-12-02

QUANTA LITE TOXOPLASMA IGG

Applicant Inova Diagnostics, Inc.

K number K971441

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LGD 1997-10-22

TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K971989

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LGD 1997-10-21

SERAQUEST TOXOPLASMA IGM

Applicant Quest Intl., Inc.

K number K971672

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LGD 1997-05-01

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY

Applicant Incstar Corp.

K number K963289

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LGD 1997-04-24

IMMULITE TOXOPLASMA QUANTITATIVE IGG

Applicant Diagnostic Products Corp.

K number K962936

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LGD 1997-03-24

TOXO IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K962343

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LGD 1996-12-16

INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)

Applicant Incstar Corp.

K number K963297

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LGD 1996-12-16

INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)

Applicant Incstar Corp.

K number K963296

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LGD 1996-08-23

AXSYM TOXO IGM

Applicant Abbott Laboratories

K number K954576

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LGD 1996-08-16

AXSYM TOXO IGG ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K954575

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LGD 1996-08-02

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

Applicant Bayer Corp.

K number K955760

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LGD 1996-06-17

SERAQUEST TOXOPLASMA IGG

Applicant Quest Intl., Inc.

K number K960092

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LGD 1996-05-14

TOXOSTAT

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

K number K944867

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LGD 1996-02-23

IMMULITE TOXOPLASMA GONDII IGG

Applicant Diagnostic Products Corp.

K number K950671

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LGD 1995-12-20

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

Applicant Bio-Rad Laboratories, Inc.

K number K951495

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LGD 1995-08-01

IMX TOXO IGG

Applicant Abbott Laboratories

K number K951636

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LGD 1995-04-27

IMX(R) TOXO IGM

Applicant Abbott Laboratories

K number K945634

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LGD 1993-06-21

VIDAS TOXO COMPETITION (TXC) ASSAY

Applicant Biomerieux Vitek, Inc.

K number K931334

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LGD 1993-05-11

VIDAS TOXO IG6 ASSAY (TX6)

Applicant Biomerieux Vitek, Inc.

K number K922737

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LGD 1993-02-25

VIDAS TOXOPLASMA GONDII IGM ASSSAY

Applicant Biomerieux Vitek, Inc.

K number K923166

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LGD 1992-09-14

OPUS(R) TOXO-G TEST SYSTEM

Applicant Pb Diagnostics, Inc.

K number K921523

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LGD 1992-09-02

BARTELS TOXOPLASMA IGG EIA

Applicant Baxter Diagnostics, Inc.

K number K922585

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LGD 1992-09-02

BARTELS TOXOPLASMA IGM EIA

Applicant Baxter Diagnostics, Inc.

K number K922579

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LGD 1992-07-08

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO

Applicant Pharmacia Diagnostics, Inc.

K number K920702

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LGD 1992-04-29

ENZYGNOST(R) TOXOPLASMOSIS/IGG

Applicant Behring Diagnostics, Inc.

K number K913731

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LGD 1992-03-04

TOXO IGG ELISA TEST (MODIFIED)

Applicant Gull Laboratories, Inc.

K number K915891

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LGD 1992-03-04

ENZYGNOST TOXOPLASMOSIS/IGM

Applicant Behring Diagnostics, Inc.

K number K913505

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LGD 1992-01-23

ELISA TOXO IGM

Applicant Sclavo, Inc.

K number K914852

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LGD 1991-12-18

TOXOPLASMA IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K913787

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LGD 1991-11-29

ABBOTT IMX TOXO IGM POSITIVE CONTROL

Applicant Abbott Laboratories

K number K913106

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LGD 1991-08-12

OPUS(R) ROZO

Applicant Pb Diagnostic Systems, Inc.

K number K911834

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LGD 1991-02-26

ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL

Applicant Abbott Laboratories

K number K910416

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LGD 1990-12-18

TOXO-CUBE

Applicant Difco Laboratories, Inc.

K number K903968

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LGD 1990-10-16

TOXO IGM ELISA TEST

Applicant Gull Laboratories, Inc.

K number K903324

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LGD 1990-07-24

TOXOPLASMA GONDII IGG

Applicant Pharmacia Diagnostics, Inc.

K number K902792

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LGD 1990-04-30

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.

Applicant Vitek Systems, Inc.

K number K900818

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LGD 1990-04-16

TOXO IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K900354

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LGD 1990-03-15

PLATELIA TOXO IGM KIT

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

K number K894948

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LGD 1990-03-06

MODIFIED CAPTIA(R) TOXO-M

Applicant Mercia Diagnostics , Ltd.

K number K900655

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LGD 1989-12-18

DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST

Applicant Gull Laboratories, Inc.

K number K893200

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LGD 1989-07-14

TOXO ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K891781

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LGD 1989-06-23

IMX TOXO IGM ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K890032

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LGD 1989-06-23

IMX TOXO IGG ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K890031

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LGD 1989-04-12

IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT

Applicant Orgenics, Ltd.

K number K885344

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LGD 1989-04-10

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K884249

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LGD 1989-02-07

MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA

Applicant Labsystems, Inc.

K number K890154

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LGD 1989-02-07

ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K883937

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LGD 1989-01-24

TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA

Applicant Lmd Laboratories

K number K883720

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LGD 1988-10-06

ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K883936

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LGD 1988-09-30

TOXOPLASMA GONDII IGG ELISA KIT

Applicant De Ferris Laboratories, Inc.

K number K875258

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LGD 1988-08-01

CAPTIA TOXO-G

Applicant Mercia Diagnostics , Ltd.

K number K880918

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LGD 1988-04-21

SERODOT TOXOPLASMA IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K875363

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LGD 1988-04-12

TOXOSTAT M TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K875113

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LGD 1988-04-12

BIOTROL TOXO ELISA TEST G

Applicant Biotrol, USA, Inc.

K number K873294

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LGD 1988-04-12

BIOTROL TOXO ELISA TEST M

Applicant Biotrol, USA, Inc.

K number K873293

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LGD 1988-03-07

DETECTADOT SYSTEM 2000 TOXO IGG TEST

Applicant Gull Laboratories, Inc.

K number K875109

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LGD 1988-03-07

TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

Applicant Clinical Sciences, Inc.

K number K874594

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LGD 1987-10-20

CHROMOTITRE E.I.A. TOXOPLASMA IGM

Applicant Ismunit Istituto Immunologico Intaliano

K number K872070

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LGD 1987-07-31

CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY

Applicant Mercia Diagnostics , Ltd.

K number K871746

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LGD 1987-07-30

TOXOPLASMA GONDII IGG ELISA

Applicant Electro-Nucleonics Laboratories, Inc.

K number K871905

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LGD 1987-07-01

MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT

Applicant Labsystems, Inc.

K number K872252

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LGD 1987-04-28

TOXOPLASMA IGM MICROASSAY

Applicant Diamedix Corp.

K number K870753

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LGD 1987-02-20

ACCUPOINT TOXO

Applicant Syva Co.

K number K865068

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LGD 1986-11-28

TOXOPLASMA IGG MICROASSAY

Applicant Diamedix Corp.

K number K863813

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LGD 1986-11-13

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY

Applicant Cytotech, Inc.

K number K863363

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LGD 1986-09-11

TOXONOSTIKA IGM MICROELISA SYSTEM

Applicant Organon Teknika Corp.

K number K862196

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LGD 1986-09-08

ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM

Applicant Organon Teknika Corp.

K number K862189

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LGD 1986-06-30

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

Applicant Labsystems, Inc.

K number K862216

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LGD 1986-06-13

MUREX SUDS TOXO

Applicant Murex Corp.

K number K861458

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LGD 1986-05-23

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560

Applicant Clinical Sciences, Inc.

K number K860773

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LGD 1985-07-09

ABBOTT TOXO-M EIA DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K850567

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LGD 1985-01-04

CORDIA T-M

Applicant Cordis Corp.

K number K843417

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