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 Size Device Size Type Device Class Implantable

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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
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)
Beta Human Chorionic Gonadotropin Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445107
In Commercial Distribution

  • 00842768015540 ()
  • 00630414004808 ()
K6430

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay
Vancomycin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445128
In Commercial Distribution

  • 00842768015533 ()
  • 00630414004990 ()
K4086

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Valproic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445127
In Commercial Distribution

  • 00842768015526 ()
  • 00630414004983 ()
K4078

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Uric Acid Flex® reagent cartridge, 560 tests
Siemens Healthcare Diagnostics Inc.
10445145
In Commercial Distribution

  • 00842768015519 ()
  • 00630414005126 ()
K1077

  • Uric acid IVD, kit, spectrophotometry
Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 180 Tests
Siemens Healthcare Diagnostics Inc.
10445168
In Commercial Distribution

  • 00842768015502 ()
  • 00630414005270 ()
K3026

  • Total protein IVD, kit, spectrophotometry
Thyronine Uptake Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445102
In Commercial Distribution

  • 00842768015496 ()
  • 00630414004761 ()
K6075

  • Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)
Triglyceride Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445093
In Commercial Distribution

  • 00842768015489 ()
  • 00630414004709 ()
K2069

  • Triglyceride IVD, kit, spectrophotometry
Tobramycin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10445121
In Commercial Distribution

  • 00842768015472 ()
  • 00630414004945 ()
K4014

  • Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Total Iron Binding Capacity Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10445134
In Commercial Distribution

  • 00842768015465 ()
  • 00630414005041 ()
K3084

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
Theophylline Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445126
In Commercial Distribution

  • 00842768015458 ()
  • 00630414004976 ()
K4071

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445116
In Commercial Distribution

  • 00842768015441 ()
  • 00630414004891 ()
K5095

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Thyroxine Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445101
In Commercial Distribution

  • 00842768015434 ()
  • 00630414004754 ()
K6065

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Salicylate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445108
In Commercial Distribution

  • 00842768015427 ()
  • 00630414004815 ()
K5020

  • Salicylate IVD, kit, spectrophotometry
Phenytoin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445125
In Commercial Distribution

  • 00842768015410 ()
  • 00630414004969 ()
K4064

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Procainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445130
Not in Commercial Distribution

  • 00842768015403 ()
  • 00630414005010 ()
K4110

  • Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445124
In Commercial Distribution

  • 00842768015397 ()
  • 00630414004952 ()
K4060

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
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