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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No Description
Microgenics Corporation
CAI-XLL
In Commercial Distribution

  • 00884883002371 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL3
In Commercial Distribution

  • 00884883002364 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL2
In Commercial Distribution

  • 00884883002357 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL1
In Commercial Distribution

  • 00884883002340 ()


  • Multiple cardiac marker IVD, control
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
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
InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control
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