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Panels › Clinical Chemistry › Product code MMI · Class 2

Immunoassay Method, Troponin Subunit

Regulation 862.1215

1510(k)s in 12 months (95 all time)
0recalls in 12 months (56 all time)
54recalls that name a 510(k)
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Top companies in MMI

DateFirm and productCodeLinked 510(k)
Dec 20, 2024Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Open, Classified
MMIK121214
K172783 +2
Aug 8, 2023ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Open, Classified
MMIK062838
K992366
Aug 8, 2023ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Open, Classified
MMIK062838
K992366
Jul 7, 2023QUIDEL CARDIOVASCULAR INC
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
Open, Classified
MMIK030286
Jul 26, 2022Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Open, Classified
MMIK041192
Jul 6, 2022Siemens Healthcare Diagnostics, Inc.
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Mater
Terminated
MMINone listed
Jul 6, 2022Siemens Healthcare Diagnostics, Inc.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Mate
Terminated
MMINone listed
Aug 9, 2021Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Open, Classified
MMIK172783
K172787
Apr 7, 2021Roche Diagnostics Operations, Inc.
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Open, Classified
MMIK082699
Apr 7, 2021Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Open, Classified
MMIK082699
Aug 19, 2020Siemens Healthcare Diagnostics, Inc.
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 1
Terminated
MMIK190675
Jul 24, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 1
Terminated
MMIK182225
Oct 16, 2019Abbott Point Of Care Inc.
i-STAT cTnI cartridge
Terminated
MMIK031739
K051433
May 29, 2019Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used a
Terminated
MMIK051650
May 4, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge
Terminated
MMIK063756
Mar 21, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
Terminated
MMIK081643
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
Terminated
MMIK012820
May 5, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Troponin 1 (TNI) Flex reagent cartridge
Terminated
MMIK081643
May 2, 2016Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac trop
Terminated
MMIK053020
Jan 7, 2016Siemens Healthcare Diagnostics Inc
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
Terminated
MMIK051650
Jul 23, 2015Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum,
Terminated
MMIK053020
Dec 12, 2014Siemens Healthcare Diagnostics, Inc.
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Terminated
MMIK991795
Jul 2, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Terminated
MMIK053020
Jan 24, 2013Abbott Point of Care Canada Limited
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plas
Terminated
MMIK031739
Aug 22, 2012Abbott Point Of Care Inc.
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac
Terminated
MMIK031739
Aug 9, 2012Abbott Point Of Care Inc.
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma sampl
Terminated
MMIK031739
May 10, 2012Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratori
Terminated
MMIK041192
Apr 26, 2012Alere San Diego
Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in
Terminated
MMIK080269
Apr 26, 2012Alere San Diego
Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart fai
Terminated
MMIK080269
Apr 11, 2012Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial i
Terminated
MMIK082699
Apr 11, 2012Roche Diagnostics Operations, Inc.
Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarc
Terminated
MMIK082699
Nov 10, 2011Abbott Point Of Care Inc.
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
Terminated
MMIK031739
Apr 4, 2011Beckman Coulter Inc.
Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of c
Terminated
MMIK010429
K021814
Mar 18, 2011Siemens Healthcare Diagnostics, Inc.
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in hepar
Terminated
MMIK051650
Nov 24, 2010Siemens Healthcare Diagnostics, Inc.
The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Terminated
MMIK081643
Sep 11, 2010Siemens Healthcare Diagnostics, Inc.
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
Terminated
MMIK051650
Jul 12, 2010Beckman Coulter Inc.
Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ca
Terminated
MMIK010429
K021814
Apr 12, 2010Beckman Coulter Inc.
Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 The intended
Terminated
MMIK010429
K021814
Feb 25, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the
Terminated
MMIK010313
Aug 12, 2009Siemens Healthcare Diagnostics, Inc.
Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test inten
Terminated
MMIK010313
May 8, 2009Biosite Inc
Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determi
Terminated
MMIK030286
Apr 15, 2009Abbott Laboratories
AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-
Terminated
MMIK060875
Jun 5, 2008Siemens Medical Solutions Diagnostics
ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, T
Terminated
MMIK053020
Apr 28, 2008Siemens Healthcare Diagnostics, Inc.
Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer.
Terminated
MMIK051650
Mar 19, 2008Beckman Coulter Inc
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
Terminated
MMIK023764
Jul 11, 2007Abbott Laboratories
AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
MMIK041811
Jun 14, 2007Abbott Laboratories MPG
ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Ab
Terminated
MMIK041192
May 26, 2007Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
Terminated
MMIK031031
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic.
Terminated
MMIK981098
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic.
Terminated
MMIK033487

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