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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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Dimension Human Chorionic Gonadotropin Flex reagent cartridge - 00842768013911

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444914
In Commercial Distribution

  • 00842768013911 ()
  • 00630414004013 ()
RF530

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013904

Cardiac Troponin-I Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10444896
In Commercial Distribution

  • 00842768013904 ()
  • 00630414003870 ()
RF521

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge - 00842768013898

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)

Dimension® clinical chemistry system FPSA Flex® reagent cartridge - 00842768013881

Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)

Dimension® clinical chemistry system TPSA Flex® reagent cartridge - 00842768013874

Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444889
In Commercial Distribution

  • 00842768013874 ()
  • 00630414601762 ()
RF451

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge FERR - 00842768013867

Ferritin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444946
In Commercial Distribution

  • 00842768013867 ()
  • 00630414004334 ()
RF440

  • Ferritin IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG - 00842768013850

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444913
In Commercial Distribution

  • 00842768013850 ()
  • 00630414004006 ()
RF430

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO - 00842768013843

Myoglobin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444907
In Commercial Distribution

  • 00842768013843 ()
  • 00630414003955 ()
RF422A

  • Myoglobin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013836

Cardiac Troponin-I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444905
In Commercial Distribution

  • 00842768013836 ()
  • 00630414003931 ()
RF421C

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge - 00842768013829

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)
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