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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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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
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