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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Syva® Emit® 2000 Carbamazepine Calibrators
Siemens Healthcare Diagnostics Inc.
10445310
In Commercial Distribution

  • 00842768000935 ()
4F109UL

  • Carbamazepine therapeutic drug monitoring IVD, calibrator
Syva® Emit® Carbamazepine Assay
Siemens Healthcare Diagnostics Inc.
10445309
In Commercial Distribution

  • 00842768000928 ()
4F019UL

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methadone Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445428
In Commercial Distribution

  • 00842768000157 ()
9E129UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Ethosuximide Assay
Siemens Healthcare Diagnostics Inc.
10445367
In Commercial Distribution

  • 00842768000140 ()
6E119UL

  • Ethosuximide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methadone Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445426
In Commercial Distribution

  • 00842768000133 ()
9E029UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Sample Diluent, 2 bottles, 50 mL per bottle
Siemens Healthcare Diagnostics Inc.
10444875
In Commercial Distribution

  • 00842768000119 ()
  • 00630414016948 ()
791092901

  • Buffered sample diluent IVD
Enzyme Diluent, 10x10mL
Siemens Healthcare Diagnostics Inc.
10444870
In Commercial Distribution

  • 00842768000102 ()
  • 00630414003771 ()
790035901

  • Buffered sample diluent IVD
Purified Water Diluent, 3.5 Liter
Siemens Healthcare Diagnostics Inc.
10444887
In Commercial Distribution

  • 00842768000096 ()
710615901

  • Buffered sample diluent IVD
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
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