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® 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
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
Triage Cardio2 Panel
QUIDEL CARDIOVASCULAR INC.
97500EU
In Commercial Distribution

  • 30014613337973 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardio3 Panel
QUIDEL CARDIOVASCULAR INC.
97400EU
In Commercial Distribution

  • 30014613337966 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Profiler SOB Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97300EU
In Commercial Distribution

  • 30014613337959 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (CK/TnI)
QUIDEL CARDIOVASCULAR INC.
97022HS
In Commercial Distribution

  • 30014613337942 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
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