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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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
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.
BIOMERIEUX SA
30421-01
Not in Commercial Distribution

  • 03573026161613 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
BB 12 L 10 to 60
NOVATECH
026951R
In Commercial Distribution

  • EBES026951R0 ()
026951R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 12 L 10 to 60
NOVATECH
026951
In Commercial Distribution

  • EBES0269510 ()
  • EBES0269511 ()
026951

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 11 L 10 to 60
NOVATECH
026901R
Not in Commercial Distribution

  • EBES026901R0 ()
026901R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 11 L 10 to 60
NOVATECH
026901
Not in Commercial Distribution

  • EBES0269010 ()
  • EBES0269011 ()
026901

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
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