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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Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 Tests
Siemens Healthcare Diagnostics Inc.
10445096
In Commercial Distribution

  • 00842768015267 ()
  • 00630414004716 ()
K3131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Lactic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445153
In Commercial Distribution

  • 00842768015243 ()
  • 00630414005171 ()
K3016

  • Lactate IVD, kit, spectrophotometry
Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10445135
In Commercial Distribution

  • 00842768015236 ()
  • 00630414005058 ()
K3085

  • Iron IVD, kit, spectrophotometry
Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests
Siemens Healthcare Diagnostics Inc.
10445150
In Commercial Distribution

  • 00842768015229 ()
  • 00630414005157 ()
K2045

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Gentamicin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10445120
In Commercial Distribution

  • 00842768015212 ()
  • 00630414004938 ()
K4012

  • Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Free Thyroxine Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445103
In Commercial Distribution

  • 00842768015205 ()
  • 00630414004778 ()
K6410

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free Triiodothyronine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445106
In Commercial Distribution

  • 00842768015199 ()
  • 00630414004792 ()
K6416

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Ferritin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10445136
In Commercial Distribution

  • 00842768015182 ()
  • 00630414005065 ()
K6440

  • Ferritin IVD, kit, chemiluminescent immunoassay
Cardiac Troponin I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445098
Not in Commercial Distribution

  • 00842768015151 ()
  • 00630414004730 ()
K6421

  • Troponin I IVD, kit, chemiluminescent immunoassay
Cyclosporine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445139
Not in Commercial Distribution

  • 00842768015144 ()
  • 00630414005089 ()
K4089

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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