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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LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707957
Not in Commercial Distribution

  • 00842768037528 ()
  • 00630414006000 ()
KC682

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707956
Not in Commercial Distribution

  • 00842768037511 ()
  • 00630414005997 ()
KC681

  • 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
Mycophenolic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10706859
In Commercial Distribution

  • 00842768036217 ()
DF215

  • Mycophenolate therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Siemens Healthcare Diagnostics Inc.
10700796
In Commercial Distribution

  • 00842768035432 ()
DC207

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Tacrolimus Flex® reagent cartridge, TAC, 80 tests (4 x 20)
Siemens Healthcare Diagnostics Inc.
10700795
In Commercial Distribution

  • 00842768035425 ()
  • 00630414005980 ()
DF207

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Lithium Flex® reagent cartridge, 180 tests
Siemens Healthcare Diagnostics Inc.
10635870
In Commercial Distribution

  • 00842768035326 ()
  • 00630414005935 ()
K4150

  • Lithium therapeutic drug monitoring IVD, kit, spectrophotometry
Drug 4 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10476171
In Commercial Distribution

  • 00842768035319 ()
KC460A

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Enzyme 2 Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10475527
In Commercial Distribution

  • 00842768034343 ()
KC321

  • Multiple clinical chemistry enzyme IVD, calibrator
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