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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Phosphorus Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445144
In Commercial Distribution

  • 00842768015700 ()
  • 00630414005119 ()
K1061

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Magnesium Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445158
In Commercial Distribution

  • 00842768015694 ()
  • 00630414005201 ()
K3057

  • Magnesium (Mg2+) IVD, kit, spectrophotometry
Glucose Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10445162
In Commercial Distribution

  • 00842768015663 ()
  • 00630414005232 ()
K1039

  • Glucose IVD, kit, spectrophotometry
EMPTY Flex® reagent cartridge, 4 Flex® reagent cartridges
Siemens Healthcare Diagnostics Inc.
10445218
In Commercial Distribution

  • 00842768015656 ()
  • 00630414005423 ()
KS999

  • Assay container IVD, single-use
Direct Bilirubin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10445152
In Commercial Distribution

  • 00842768015649 ()
  • 00630414005164 ()
K2125

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Carbon Dioxide Flex® reagent cartridge, 3360 Tests
Siemens Healthcare Diagnostics Inc.
10445163
In Commercial Distribution

  • 00842768015625 ()
  • 00630414005249 ()
K1137

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Calcium Flex® reagent cartridge, 1320 tests
Siemens Healthcare Diagnostics Inc.
10445160
In Commercial Distribution

  • 00842768015618 ()
  • 00630414005225 ()
K1023

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Urea Nitrogen Flex® reagent cartridge, 1680 Tests
Siemens Healthcare Diagnostics Inc.
10445159
In Commercial Distribution

  • 00842768015601 ()
  • 00630414005218 ()
K1021

  • Urea IVD, kit, enzyme spectrophotometry
Aspartate Aminotransferase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10445148
In Commercial Distribution

  • 00842768015595 ()
  • 00630414005140 ()
K2041

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Urine Ecstasy Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445119
In Commercial Distribution

  • 00842768015557 ()
  • 00630414004921 ()
K5109

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
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