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 Class Implantable

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Quiklyte Diluent Check, 60mL
Siemens Healthcare Diagnostics Inc.
10444872
In Commercial Distribution

  • 00842768014024 ()
S640

  • Multiple electrolyte IVD, reagent
Sample Diluent, 6x500mL
Siemens Healthcare Diagnostics Inc.
10444874
In Commercial Distribution

  • 00842768014017 ()
  • 00630414003795 ()
S635

  • Multiple electrolyte IVD, reagent
QuikLYTE® Integrated Multisensor Standard B, 3x300mL
Siemens Healthcare Diagnostics Inc.
10444881
In Commercial Distribution

  • 00842768014000 ()
  • 00630414003818 ()
S625

  • Multiple electrolyte IVD, calibrator
QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter
Siemens Healthcare Diagnostics Inc.
10444878
In Commercial Distribution

  • 00842768013997 ()
  • 00630414003801 ()
S620

  • Multiple electrolyte IVD, calibrator
Dimension® Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5)
Siemens Healthcare Diagnostics Inc.
10445044
In Commercial Distribution

  • 00842768013928 ()
RXV1A

  • Laboratory waste receptacle liner IVD
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)
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)
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)
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)
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)
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