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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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
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)
Cholesterol Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445143
In Commercial Distribution

  • 00842768015090 ()
  • 00630414005102 ()
K1027

  • Total cholesterol lipid IVD, kit, spectrophotometry
Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445118
In Commercial Distribution

  • 00842768015083 ()
  • 00630414004914 ()
K5097

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Urine Barbiturates Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445117
In Commercial Distribution

  • 00842768015076 ()
  • 00630414004907 ()
K5096

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Amylase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445154
In Commercial Distribution

  • 00842768015069 ()
  • 00630414005188 ()
K3017

  • Total amylase IVD, kit, spectrophotometry
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