Immunoassay Method, Troponin Subunit

MMI 2025-10-29

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Applicant Ortho-Clinical Diagnostics, Inc.

K number K252393

MMI 2025-08-01

Access hsTnI

Applicant Beckman Coulter, Inc.

K number K243483

MMI 2025-06-16

Access hsTnI

Applicant Beckman Coulter, Inc.

K number K242870

MMI 2025-01-03

i-STAT hs-TnI cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K number K240984

MMI 2024-07-25

Atellica® IM High-Sensitivity Troponin I (TnIH)

K number K241165

MMI 2024-03-20

PATHFAST®hs-cTnI-II

Applicant Phc Corporation

K number K231974

MMI 2023-12-18

Access hsTnI

Applicant Beckman Coulter, Inc.

K number K222881

MMI 2023-12-04

Access hsTnI

Applicant Beckman Coulter, Inc.

K number K230648

MMI 2023-05-04

Alinity i STAT High Sensitivity Troponin-I

Applicant Abbott Laboratories Diagnostics Division

K number K230994

MMI 2022-05-19

Alinity i STAT High Sensitivity Troponin-I

Applicant Abbott Laboratories Diagnostics Division

K number K202525

MMI 2021-09-21

Elecsys Troponin T Gen 5

Applicant Roche Diagnostics

K number K201441

MMI 2019-09-13

ARCHITECT STAT High Sensitivity Troponin-I

Applicant Abbott Laboratories Diagnostics Division

K number K191595

MMI 2019-05-17

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

K number K190675

MMI 2019-03-04

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

K number K182225

MMI 2018-07-19

Atellica IM High-Sensitivity Troponin I (TNIH)

K number K171566

MMI 2018-07-12

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

K number K171274

MMI 2018-06-14

Access hsTnl

Applicant Beckman Coulter, Inc.

K number K172787

MMI 2018-06-12

Access hs Tnl

Applicant Beckman Coulter, Inc.

K number K172783

MMI 2017-01-18

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

Applicant Roche Diagnostics

K number K162895

MMI 2013-09-25

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

Applicant Beckman Coulter, Inc.

K number K121790

MMI 2013-06-14

ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM

Applicant Beckman Coulter, Inc.

K number K121214

MMI 2011-05-16

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

Applicant Mitsubishi Chemical Medience CO

K number K100130

MMI 2010-10-20

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

Applicant Nano-Ditech Corporation

K number K102441

MMI 2010-10-20

NANO-CHECK AMI CTNI CARDIAC MARKER TEST

Applicant Nano-Ditech Corporation

K number K102131

MMI 2009-08-19

ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

Applicant Roche Diagnostics

K number K082699

MMI 2008-07-03

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

Applicant Siemens Healthcare Diagnostics

K number K081643

MMI 2007-12-14

VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

Applicant bioMerieux, Inc.

K number K063243

MMI 2007-09-13

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

Applicant Fisher Diagnostics

K number K070640

MMI 2007-03-19

DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K063756

MMI 2006-12-19

VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

Applicant Ortho-Clinical Diagnostics

K number K062838

MMI 2006-06-14

ABBOTT AXSYM TROPONIN-I ADV

Applicant Abbott Laboratories

K number K060875

MMI 2006-04-14

DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

Applicant Dade Behring, Inc.

K number K053577

MMI 2006-03-02

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

Applicant Nano-Ditech Co.

K number K050975

MMI 2005-12-30

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

Applicant Bayer Healthcare, LLC

K number K053020

MMI 2005-12-14

TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

Applicant Bayer Healthcare, LLC

K number K052503

MMI 2005-11-29

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

Applicant Access Bio Incorporate

K number K051925

MMI 2005-08-17

VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT

Applicant Vancouver Biotech , Ltd.

K number K050644

MMI 2005-07-11

ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)

Applicant Roche Diagnostics

K number K051752

MMI 2004-12-17

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

Applicant Biocheck, Inc.

K number K041619

MMI 2004-11-19

INSTANT-VIEW TROPONIN I TEST

Applicant Alfa Scientific Designs, Inc.

K number K042227

MMI 2004-09-10

ABBOTT AXSYM TROPONIN-I ADV

Applicant Abbott Laboratories

K number K041811

MMI 2004-08-12

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

Applicant Fisher Diagnostics

K number K041192

MMI 2004-05-17

ELECSYS TROPONIN T STAT TEST

Applicant Roche Diagnostics Corp.

K number K040733

MMI 2004-05-17

RAMP TROPONIN I ASSAY

Applicant Response Biomedical Corp.

K number K033745

MMI 2003-12-24

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

Applicant Dade Behring, Inc.

K number K033487

MMI 2003-09-29

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K031031

MMI 2003-09-02

I-STAT CARDIAC TROPONIN (CTNI) TEST

Applicant I-Stat Corporation

K number K031739

MMI 2003-06-16

VIDAS TROPONIN I (TNI), MODEL 30 445

Applicant bioMerieux, Inc.

K number K030950

MMI 2003-03-31

VBL SERUM TROPONIN I TEST, MODEL 1001

Applicant Vancouver Biotech , Ltd.

K number K023505

MMI 2003-03-19

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

K number K030057

MMI 2003-02-21

MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS

Applicant Ortho-Clinical Diagnostics

K number K024193

MMI 2002-10-08

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

Applicant Princeton BioMeditech Corp.

K number K022946

MMI 2002-09-27

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345

Applicant Beckman Coulter, Inc.

K number K021814

MMI 2002-05-24

SPECTRAL'S 2 IN 1 (TNI-MYO)

K number K020950

MMI 2002-04-12

MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

Applicant Ortho-Clinical Diagnostics

K number K020662

MMI 2002-02-01

SPECTRAL'S TROPONIN I

K number K014105

MMI 2002-01-08

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

Applicant Biocheck, Inc.

K number K013062

MMI 2001-12-18

MODIFICATION TO ALPHA DX SYSTEM

Applicant First Medical, Inc.

K number K014024

MMI 2001-12-14

AIA-PACK CTNI 2ND-GEN ASSAY

Applicant Tosoh Medics, Inc.

K number K012820

MMI 2001-06-05

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345

Applicant Beckman Coulter, Inc.

K number K010429

MMI 2001-04-20

DIMENSION CTNI FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K010313

MMI 2001-03-29

BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K010201

MMI 2001-03-13

ALPHA DX SYSTEM

Applicant First Medical, Inc.

K number K010562

MMI 2000-05-18

THE CARDIAC READER SYSTEM

Applicant Roche Diagnostics Corp.

K number K000784

MMI 1999-12-06

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K993353

MMI 1999-12-06

BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY

Applicant Bayer Corp.

K number K993309

MMI 1999-10-08

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK

Applicant Ortho-Clinical Diagnostics, Inc.

K number K992366

MMI 1999-10-04

CARDIOQUANT TROPONIN I TEST

K number K992127

MMI 1999-07-01

OPUS TROPONIN I (CTN) TEST MODULES

Applicant Dade Behring, Inc.

K number K991177

MMI 1999-06-09

IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5

Applicant Diagnostic Products Corp.

K number K991795

MMI 1998-12-23

AIA-PACK TROPONIN I ASSAY

Applicant Tosoh Medics, Inc.

K number K984359

MMI 1998-12-14

STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK

Applicant Dade Behring, Inc.

K number K984093

MMI 1998-12-08

ELECSYS TROPONIN T STAT TEST

K number K984105

MMI 1998-12-07

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15

Applicant Diagnostic Products Corp.

K number K983972

MMI 1998-07-06

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

Applicant Princeton BioMeditech Corp.

K number K981882

MMI 1998-04-27

STRATUS CS CARDIAC TROPONIN I TESTPAK

Applicant Dade Behring, Inc.

K number K981098

MMI 1998-03-03

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)

Applicant Chiron Diagnostics Corp.

K number K980528

MMI 1998-02-04

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

Applicant First Medical, Inc.

K number K974839

MMI 1998-01-16

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM

Applicant Radiometer America, Inc.

K number K974818

MMI 1997-12-05

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K973616

MMI 1997-11-25

ABBOTT AXSYM TROPONIN-I

Applicant Abbott Laboratories

K number K974103

MMI 1997-11-10

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Applicant Beckman Instruments, Inc.

K number K974075

MMI 1997-10-20

TROPONIN (TROP) METHOD

Applicant Dade Chemistry Systems, Inc.

K number K973650

MMI 1997-07-23

TARGET CARDIAC TROPONIN I TEST

Applicant Texas Immunology, Inc.

K number K972094

MMI 1997-02-10

TROPONIN-I TEST SYSTEM

Applicant Dade Intl., Inc.

K number K964862

MMI 1997-02-10

CARDIAC T TROPONIN T RAPID ASSAY

K number K964372

MMI 1996-12-16

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

Applicant Bio-Rad Laboratories, Inc.

K number K963934

MMI 1996-11-07

CARDIAC STATUS TROPONIN I

Applicant Princeton BioMeditech Corp.

K number K963513

MMI 1996-06-11

ELECSYS TROPONIN T

K number K961500

MMI 1996-02-14

BOEHRINGER MANNHEIM CARDIAC T TROPNIN T

K number K955868

MMI 1996-01-25

OPUS TROPONIN I

Applicant Behring Diagnostics, Inc.

K number K955284

MMI 1995-11-09

BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY

K number K952478

MMI 1995-07-13

STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS

Applicant Dade Intl., Inc.

K number K951890

MMI 1994-04-26

CARDIAC T ELISA TROPONIN-T

K number K924392