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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InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009963
In Commercial Distribution

  • 03610522114405 ()
12009963

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009962
In Commercial Distribution

  • 03610522114399 ()
12009962

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009961
In Commercial Distribution

  • 03610522114382 ()
12009961

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009960
In Commercial Distribution

  • 03610522114375 ()
12009960

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009959
In Commercial Distribution

  • 03610522114368 ()
12009959

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009958
In Commercial Distribution

  • 03610522114351 ()
12009958

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009957
In Commercial Distribution

  • 03610522114344 ()
12009957

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009956
In Commercial Distribution

  • 03610522114337 ()
12009956

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009955
In Commercial Distribution

  • 03610522114320 ()
12009955

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 3 MiniPak (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006371
In Commercial Distribution

  • 03610521174943 ()
12006371

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 2 MiniPak (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006370
In Commercial Distribution

  • 03610521174936 ()
12006370

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006369
In Commercial Distribution

  • 03610521174929 ()
12006369

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006239
In Commercial Distribution

  • 03610521174905 ()
12006239

  • 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
No Description
Roche Diagnostics GmbH
4917049160
In Commercial Distribution

  • 04015630939138 ()
4917049160

  • Multiple cardiac marker IVD, control
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
No Description
AALTO SCIENTIFIC
K982M-5
In Commercial Distribution

  • B085K982M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K936M-5
In Commercial Distribution

  • B085K936M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K935M-5
In Commercial Distribution

  • B085K935M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K908M-5
In Commercial Distribution

  • B085K908M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K906M-5
In Commercial Distribution

  • B085K906M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K891M-5
In Commercial Distribution

  • B085K891M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K887M-5
In Commercial Distribution

  • B085K887M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K804M-5
In Commercial Distribution

  • B085K804M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K710M-5
In Commercial Distribution

  • B085K710M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K026M-6
In Commercial Distribution

  • B085K026M60 ()


  • Multiple cardiac marker IVD, control
Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.
International Point of Care Incorporated
CSC3023
Not in Commercial Distribution

  • B103CSC30231 ()
  • B103CSC30230 ()
CSC3023

  • 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
C5003-1
In Commercial Distribution

  • 10627966005299 ()
C5003-1

  • 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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