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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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® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • 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
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
InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016484
In Commercial Distribution

  • 03610522248872 ()
12016484

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016475
In Commercial Distribution

  • 03610522248698 ()
12016475

  • Multiple cardiac marker IVD, control
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