Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004817
In Commercial Distribution

  • 03610520865323 ()
12004817

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004816
In Commercial Distribution

  • 03610520865316 ()
12004816

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004815
In Commercial Distribution

  • 03610520865309 ()
12004815

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004814
In Commercial Distribution

  • 03610520865293 ()
12004814

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004813
In Commercial Distribution

  • 03610520865286 ()
12004813

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004812
In Commercial Distribution

  • 03610520865279 ()
12004812

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004811
In Commercial Distribution

  • 03610520865262 ()
12004811

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004810
In Commercial Distribution

  • 03610520865255 ()
12004810

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004809
In Commercial Distribution

  • 03610520865248 ()
12004809

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004808
In Commercial Distribution

  • 03610520865231 ()
12004808

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004807
In Commercial Distribution

  • 03610520865224 ()
12004807

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004806
In Commercial Distribution

  • 03610520865217 ()
12004806

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control MiniPak (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12001085
In Commercial Distribution

  • 03610520551707 ()
12001085

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12001084
In Commercial Distribution

  • 03610520551356 ()
12001084

  • Multiple cardiac marker IVD, control
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
NANO-DITECH CORPORATION
TF3154
In Commercial Distribution

  • 00895160002496 ()
  • 10895160002493 ()
TF3154

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel, CK-MB and TnI
ALERE SAN DIEGO, INC.
97022HS
Not in Commercial Distribution

  • 00899722002795 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel, TnI
ALERE SAN DIEGO, INC.
97021HS
Not in Commercial Distribution

  • 00899722002788 ()
97021HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Profiler SOB™ Panel
ALERE SAN DIEGO, INC.
97300EU
Not in Commercial Distribution

  • 00899722002740 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Troponin I Test
ALERE SAN DIEGO, INC.
98600EU
Not in Commercial Distribution

  • 00893038002821 ()
98600EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-300C-01
In Commercial Distribution

  • 10743816001607 ()
LSC-300C-01

  • Multiple cardiac marker IVD, control
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-301
In Commercial Distribution

  • 10743816001355 ()
LSC-301

  • Multiple cardiac marker IVD, control
VITROS Chemistry Products Isoenzyme Performance Verifier II
ORTHO-CLINICAL DIAGNOSTICS, INC.
8748220
In Commercial Distribution

  • 10758750005154 ()
8748220

  • Multiple cardiac marker IVD, control
VITROS Chemistry Products Isoenzyme Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
8721508
In Commercial Distribution

  • 10758750005123 ()
8721508

  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C5003-1
In Commercial Distribution

  • 10627966005299 ()
C5003-1

  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C5003-2
In Commercial Distribution

  • 10627966005305 ()
C5003-2

  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C2003-3
Not in Commercial Distribution

  • 10627966005091 ()


  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C2003-2
Not in Commercial Distribution

  • 10627966005084 ()


  • Multiple cardiac marker IVD, control
No Description
Response Biomedical Corp
C2003-1
Not in Commercial Distribution

  • 10627966005077 ()


  • Multiple cardiac marker IVD, control
Cardiac Calibration Verifiers for Beckman Systems
CLINIQA CORPORATION
98232
In Commercial Distribution

  • 00817238011643 ()


  • Multiple cardiac marker IVD, control
Cardiac Calibration Verifiers for Roche Systems
CLINIQA CORPORATION
98505
In Commercial Distribution

  • 00817238011636 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 3
CLINIQA CORPORATION
91492
In Commercial Distribution

  • 00817238011629 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 2
CLINIQA CORPORATION
91491
In Commercial Distribution

  • 00817238011612 ()


  • Multiple cardiac marker IVD, control
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