Product Code: MMI


Products Classified as MMI

614Immunoassay Method, Troponin SubunitCreatine Phosphokinase/creatine Kinase Or Isoenzymes Test System.

Total Product Life Cycle (TPLC) Devices

614Immunoassay Method, Troponin SubunitCreatine Phosphokinase/creatine Kinase Or Isoenzymes Test System.

Pre-market Notifications for MMI

K202525Alinity I STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division
K201441Elecsys Troponin T Gen 5Roche Diagnostics
K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division
K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.
K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.
K172787Access HsTnlBeckman Coulter, Inc.
K172783Access Hs TnlBeckman Coulter, Inc.
K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics Inc.
K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics Inc.
K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5Roche Diagnostics
K121790ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMBECKMAN COULTER, INC.
K121214ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEMBECKMAN COULTER, INC.
K102441NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBINNANO-DITECH CORPORATION
K102131NANO-CHECK AMI CTNI CARDIAC MARKER TESTNANO-DITECH CORPORATION
K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MITSUBISHI CHEMICAL MEDIENCE CO

Global Unique Device Identification Database

00380740052836IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414986098IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414986081IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414986074IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414954394IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414602929IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414602912IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414600109IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414600093IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414516226IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414516219IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414006758IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00630414006703IMMUNOASSAY METHOD, TROPONIN SUBUNIT
00811727013347Immunoassay Method, Troponin Subunit
00842768022067IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Maude Adverse Events

ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-30
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-30
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-27
ACCESS HIGH SENSITIVITY TROPONIN I REAGENTBECKMAN COULTER2020-03-25
TRIAGE CARDIAC TNI PANELQUIDEL CARDIOVASCULAR INC.2020-03-24
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-03-24
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-03-24
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-03-24
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-24
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-19
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-03-18
ACCESS ACCUTNI +3 REAGENTBECKMAN COULTER2020-03-18
ACCESS HIGH SENSITIVITY TROPONIN I REAGENTBECKMAN COULTER2020-03-18
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-16
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-13
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-13
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-13
ELECSYS TROPONIN T STAT ASSAYROCHE DIAGNOSTICS2020-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-03-12
TROPONIN T HIGH SENSITIVEROCHE DIAGNOSTICS2020-03-09
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-03-04
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-03-04
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-03-04
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-04
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-04
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-03
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-03
ACCESS ACCUTNI+3 REAGENTBECKMAN COULTER2020-03-03
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-03-02
ELECSYS TROPONIN T HSROCHE DIAGNOSTICS2020-03-02
TRIAGE CARDIAC PANELQUIDEL CARDIOVASCULAR INC.2020-02-28
TRIAGE CARDIAC PANELQUIDEL CARDIOVASCULAR INC.2020-02-28
ACCESS HIGH SENSITIVITY TROPONIN I REAGENTBECKMAN COULTER2020-02-28
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-02-25
TRIAGE CARDIAC PANELQUIDEL CARDIOVASCULAR INC.2020-02-24
DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC2020-02-24
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-02-20
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-02-20
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-02-20
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-02-20
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-02-19
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-02-19
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-02-18
ARCHITECT STAT TROPONIN-IABBOTT LABORATORIES2020-02-16
ARCHITECT STAT HIGH SENSITIVE TROPONIN-IABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD2020-02-14
ELECSYS TROPONIN T HSROCHE DIAGNOSTICS2020-02-13
ADVIA CENTAUR XPT HIGH-SENSITIVITY TROPONIN I (TNIH)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-13
ADVIA CENTAUR TNI-ULTRASIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-13
ADVIA CENTAUR TNI-ULTRASIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-13
I-STAT TROPONIN (CTNI) CARTRIDGEABBOTT POINT OF CARE2020-02-13
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