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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Chemistry 2 Calibrator, 6 (3A x 2.0 mL; 3B x 2.0 mL)
Siemens Healthcare Diagnostics Inc.
10445170
In Commercial Distribution

  • 00842768015793 ()
KC120

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Drug 2 Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10445184
In Commercial Distribution

  • 00842768015779 ()
KC420

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Drug 1 Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10445183
In Commercial Distribution

  • 00842768015762 ()
KC410

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Thyroid Stimulating Hormone Flex® reagent cartridge, 960 Tests
Siemens Healthcare Diagnostics Inc.
10445104
In Commercial Distribution

  • 00842768015731 ()
  • 00630414004785 ()
K6412

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Total Protein Flex® reagent cartridge, 1560 tests
Siemens Healthcare Diagnostics Inc.
10445167
In Commercial Distribution

  • 00842768015724 ()
  • 00630414005263 ()
K1073

  • Total protein IVD, kit, spectrophotometry
Total Bilirubin Flex® reagent cartridge, 640 Tests
Siemens Healthcare Diagnostics Inc.
10445146
In Commercial Distribution

  • 00842768015717 ()
  • 00630414005133 ()
K1167

  • Total bilirubin IVD, kit, spectrophotometry
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
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