DDR

Product Code: DDR


Products Classified as DDR

2942Myoglobin, Antigen, Antiserum, ControlMyoglobin Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2942Myoglobin, Antigen, Antiserum, ControlMyoglobin Immunological Test System.

Pre-market Notifications for DDR

K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDIAZYME LABORATORIES
K122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics Inc.
K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche Diagnostics
K080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBECKMAN COULTER, INC.
K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMROCHE DIAGNOSTICS CORP.
K042982QUANTEX MYOGLOBININSTRUMENTATION LABORATORY CO.
K042924ARCHITECT STAT MYO IMMUNOASSAYFISHER DIAGNOSTICS
K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.
K021229MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244BECKMAN COULTER, INC.
K012040RAMP MYOGLOBIN ASSAYRESPONSE BIOMEDICAL CORP.
K010700RANDOX MYOGLOBINRANDOX LABORATORIES, LTD.
K000196ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316BECKMAN COULTER, INC.
K992976K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATORKAMIYA BIOMEDICAL CO.
K991796IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5DIAGNOSTIC PRODUCTS CORP.
K991277MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5DIAGNOSTIC PRODUCTS CORP.

Global Unique Device Identification Database

00380740003296MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414964942MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414964270MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414961736MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414599687MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414599670MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414599663MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414598468MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414197197MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414197180MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414180014MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414178493MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00630414000190MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00842768015335MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
00842768013843MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Maude Adverse Events

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-08-22
MYO2 TINA-QUANT MYOGLOBIN GEN.2ROCHE DIAGNOSTICS2019-08-20
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-02-06
IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-11-07
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-10-23
VITROS IMMUNODIAGNOSTICS PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-07-20
MYOGLOBINROCHE DIAGNOSTICS2018-05-29
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2017-12-18
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2017-12-18
VITROS 5600 INTEGRATED SYSTEMORTHO-CLINICAL DIAGNOSTICS2017-09-26
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2017-08-16
ELECSYS MYOGLOBIN IMMUNOASSAYROCHE DIAGNOSTICS2017-08-09
VITROS 5600 INTEGRATED SYSTEMORTHO-CLINICAL DIAGNOSTICS2017-06-23
VITROS 5600 INTEGRATED SYSTEMORTHO-CLINICAL DIAGNOSTICS2017-06-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2017-05-24
VITROS 5600 INTEGRATED SYSTEMORTHO-CLINICAL DIAGNOSTICS2017-04-11
ELECSYS MYOGLOBIN IMMUNOASSAYROCHE DIAGNOSTICS2017-02-13
MYO2 TINA-QUANT MYOGLOBIN GEN.2ROCHE DIAGNOSTICS2017-01-04
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2016-10-11
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2016-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2016-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2014-01-16
ADVIA CENTAUR XP MYOGLOBIN ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-04-17
ADVIA CENTAUR XP MYOGLOBIN (MYO) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-03-29
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENTORTHO-CLINICAL DIAGNOSTICS2013-03-21
ARCHITECT STAT MYOGLOBIN REAGENTABBOTT LABORATORIES2012-11-09
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENTORTHO-CLINICAL DIAGNOSTICS2012-10-03
ARCHITECT STAT MYOGLOBINABBOTT LABORATORIES2011-11-17
ARCHITECT STAT MYOGLOBINABBOTT LABORATORIES2011-11-17
ARCHITECT STAT MYOGLOBINABBOTT LABORATORIES2011-11-17
MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT)ROCHE DIAGNOSTICS2011-06-06
TRIAGE PROFILER SOB PANELALERE SAN DIEGO, INC.2011-01-05
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2009-08-20
ADVIA CENTAUR MYOGLOBIN (MYO)SIEMENS HEALTHCARE DIAGNOSTICS INC.2009-03-04
AXSYM MYOGLOBINABBOTT LABORATORIES2009-02-11
BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEMBECKMAN COULTER, INC.2002-03-13
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.