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 Procainamide Calibrators
Siemens Healthcare Diagnostics Inc.
10445319
In Commercial Distribution

  • 00842768000997 ()
4K109UL

  • Procainamide therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Procainamide Assay
Siemens Healthcare Diagnostics Inc.
10445318
In Commercial Distribution

  • 00842768000980 ()
4K019UL

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 Digoxin Calibrators
Siemens Healthcare Diagnostics Inc.
10445316
In Commercial Distribution

  • 00842768000973 ()
4H209UL

  • Digoxin therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Digoxin Assay
Siemens Healthcare Diagnostics Inc.
10445315
In Commercial Distribution

  • 00842768000966 ()
4H019UL

  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Valproic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445313
In Commercial Distribution

  • 00842768000959 ()
4G109UL

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Valproic Acid Assay
Siemens Healthcare Diagnostics Inc.
10445312
In Commercial Distribution

  • 00842768000942 ()
4G019UL

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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)
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