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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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
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel
QUIDEL CARDIOVASCULAR INC.
97000HS
In Commercial Distribution

  • 30014613337911 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Quidel Triage Total 5 Calibration Verification
QUIDEL CARDIOVASCULAR INC.
88755
In Commercial Distribution

  • 30014613337126 ()
88755

  • Multiple cardiac marker IVD, control
Quidel Triage Total 5 Control 2
QUIDEL CARDIOVASCULAR INC.
88754
In Commercial Distribution

  • 30014613337119 ()
88754

  • Multiple cardiac marker IVD, control
Quidel Triage Total 5 Control 1
QUIDEL CARDIOVASCULAR INC.
88753
In Commercial Distribution

  • 30014613337102 ()
88753

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 2
QUIDEL CARDIOVASCULAR INC.
88734
In Commercial Distribution

  • 30014613337096 ()
88734

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 1
QUIDEL CARDIOVASCULAR INC.
88733
In Commercial Distribution

  • 30014613337089 ()
88733

  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-MP
In Commercial Distribution

  • 00884883012004 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-303
In Commercial Distribution

  • 00884883011984 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-101
In Commercial Distribution

  • 00884883011960 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-SP
In Commercial Distribution

  • 00884883011991 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-202
In Commercial Distribution

  • 00884883011977 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-L
In Commercial Distribution

  • 00884883011953 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-UL
In Commercial Distribution

  • 00884883011946 ()


  • Multiple cardiac marker IVD, control
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