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 CA 15-3 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464344
In Commercial Distribution

  • 00842768028526 ()
  • 00630414005591 ()
K6456

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
LOCI CA 125 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464357
In Commercial Distribution

  • 00842768028519 ()
  • 00630414005614 ()
K6455

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Alkaline Phosphatase Calibrator, 3 x 1mL
Siemens Healthcare Diagnostics Inc.
10714029
In Commercial Distribution

  • 00842768039041 ()
KC331

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator
Alkaline Phosphatase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10642444
In Commercial Distribution

  • 00842768039034 ()
  • 00630414005942 ()
K2115

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Alkaline Phosphatase calibrator, 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10714028
In Commercial Distribution

  • 00842768039027 ()
DC150

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator
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 Vista® ACLN Flex® reagent cartridge, 4 Flex® reagent cartridges per carton
Siemens Healthcare Diagnostics Inc.
10712182
In Commercial Distribution

  • 00842768037771 ()
  • 00630414016795 ()
KS343

  • Wash/cleaning solution IVD, automated/semi-automated system
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
LOCI High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics Inc.
10471068
In Commercial Distribution

  • 00842768037726 ()
  • 00630414225203 ()
RF627

  • Troponin I 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
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