Products Classified as DDR

2942

Myoglobin, Antigen, Antiserum, Control

Myoglobin Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2942

Myoglobin, Antigen, Antiserum, Control

Myoglobin Immunological Test System.

Pre-market Notifications for DDR

K123785	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	DIAZYME LABORATORIES
K122599	ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR	Siemens Healthcare Diagnostics Inc.
K083260	ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN	Roche Diagnostics
K080481	ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS	BECKMAN COULTER, INC.
K061683	TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM	ROCHE DIAGNOSTICS CORP.
K042982	QUANTEX MYOGLOBIN	INSTRUMENTATION LABORATORY CO.
K042924	ARCHITECT STAT MYO IMMUNOASSAY	FISHER DIAGNOSTICS
K033300	VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS	Ortho-Clinical Diagnostics, Inc.
K021229	MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244	BECKMAN COULTER, INC.
K012040	RAMP MYOGLOBIN ASSAY	RESPONSE BIOMEDICAL CORP.
K010700	RANDOX MYOGLOBIN	RANDOX LABORATORIES, LTD.
K000196	ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316	BECKMAN COULTER, INC.
K992976	K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR	KAMIYA BIOMEDICAL CO.
K991796	IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5	DIAGNOSTIC PRODUCTS CORP.
K991277	MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5	DIAGNOSTIC PRODUCTS CORP.

Global Unique Device Identification Database

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

Maude Adverse Events

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2019-08-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2019-08-22
MYO2 TINA-QUANT MYOGLOBIN GEN.2	ROCHE DIAGNOSTICS	2019-08-20
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2019-02-06
IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-11-07
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-10-23
VITROS IMMUNODIAGNOSTICS PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-07-20
MYOGLOBIN	ROCHE DIAGNOSTICS	2018-05-29
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2018-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2017-12-18
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2017-12-18
VITROS 5600 INTEGRATED SYSTEM	ORTHO-CLINICAL DIAGNOSTICS	2017-09-26
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2017-08-16
ELECSYS MYOGLOBIN IMMUNOASSAY	ROCHE DIAGNOSTICS	2017-08-09
VITROS 5600 INTEGRATED SYSTEM	ORTHO-CLINICAL DIAGNOSTICS	2017-06-23
VITROS 5600 INTEGRATED SYSTEM	ORTHO-CLINICAL DIAGNOSTICS	2017-06-23
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2017-05-24
VITROS 5600 INTEGRATED SYSTEM	ORTHO-CLINICAL DIAGNOSTICS	2017-04-11
ELECSYS MYOGLOBIN IMMUNOASSAY	ROCHE DIAGNOSTICS	2017-02-13
MYO2 TINA-QUANT MYOGLOBIN GEN.2	ROCHE DIAGNOSTICS	2017-01-04
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2016-10-11
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2016-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2016-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2014-01-16
ADVIA CENTAUR XP MYOGLOBIN ASSAY	SIEMENS HEALTHCARE DIAGNOSTICS, INC.	2013-04-17
ADVIA CENTAUR XP MYOGLOBIN (MYO) ASSAY	SIEMENS HEALTHCARE DIAGNOSTICS, INC.	2013-03-29
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT	ORTHO-CLINICAL DIAGNOSTICS	2013-03-21
ARCHITECT STAT MYOGLOBIN REAGENT	ABBOTT LABORATORIES	2012-11-09
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT	ORTHO-CLINICAL DIAGNOSTICS	2012-10-03
ARCHITECT STAT MYOGLOBIN	ABBOTT LABORATORIES	2011-11-17
ARCHITECT STAT MYOGLOBIN	ABBOTT LABORATORIES	2011-11-17
ARCHITECT STAT MYOGLOBIN	ABBOTT LABORATORIES	2011-11-17
MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT)	ROCHE DIAGNOSTICS	2011-06-06
TRIAGE PROFILER SOB PANEL	ALERE SAN DIEGO, INC.	2011-01-05
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK	ORTHO-CLINICAL DIAGNOSTICS	2009-08-20
ADVIA CENTAUR MYOGLOBIN (MYO)	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2009-03-04
AXSYM MYOGLOBIN	ABBOTT LABORATORIES	2009-02-11
BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM	BECKMAN COULTER, INC.	2002-03-13

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