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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 Size Device Size Type Device Class Implantable

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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)
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)
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