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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Alkaline Phosphatase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10642445
In Commercial Distribution

  • 00842768039010 ()
  • 00630414005959 ()
DF150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Dimension® EXL™ Total Vitamin D, 200 tests (4x50)
Siemens Healthcare Diagnostics Inc.
10706480
In Commercial Distribution

  • 00842768037740 ()
  • 00630414016801 ()
RF634

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
High-Sensitivity Troponin (TNIH) Dimension Vista - RGT 120T
Siemens Healthcare Diagnostics Inc.
10471067
In Commercial Distribution

  • 00842768037719 ()
  • 00630414225197 ()
K6427

  • Troponin I IVD, kit, chemiluminescent immunoassay
LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707958
Not in Commercial Distribution

  • 00842768037535 ()
  • 00630414006017 ()
KC683

  • Troponin I IVD, control
Dimension® EXL™ 200 System
Siemens Healthcare Diagnostics Inc.
10636928
In Commercial Distribution

  • 00842768037214 ()
778041.931

  • Multiple clinical chemistry analyser IVD, laboratory
Enzymatic Creatinine Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10700444
In Commercial Distribution

  • 00842768036262 ()
  • 00630414005973 ()
K1270A

  • Creatinine IVD, kit, spectrophotometry
Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Siemens Healthcare Diagnostics Inc.
10700796
In Commercial Distribution

  • 00842768035432 ()
DC207

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Lithium Flex® reagent cartridge, 180 tests
Siemens Healthcare Diagnostics Inc.
10635870
In Commercial Distribution

  • 00842768035326 ()
  • 00630414005935 ()
K4150

  • Lithium therapeutic drug monitoring IVD, kit, spectrophotometry
Dimension® EXL™/ Dimension Vista® Multi 2 sample diluent, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10483586
In Commercial Distribution

  • 00842768032417 ()
  • 00630414005799 ()
KD694

  • Buffered sample diluent IVD
LOCI Thyroid Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10484354
In Commercial Distribution

  • 00842768031694 ()
RC610A

  • Multiple thyroid marker IVD, calibrator
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