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 Tobramycin Assay
Siemens Healthcare Diagnostics Inc.
10445330
In Commercial Distribution

  • 00842768001062 ()
4S019UL

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Quinidine Calibrators
Siemens Healthcare Diagnostics Inc.
10445328
In Commercial Distribution

  • 00842768001055 ()
4Q109UL

  • Quinidine therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Qunidine Assay
Siemens Healthcare Diagnostics Inc.
10445327
In Commercial Distribution

  • 00842768001048 ()
4Q019UL

  • Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Theophylline Calibrators
Siemens Healthcare Diagnostics Inc.
10445325
In Commercial Distribution

  • 00842768001031 ()
4P109UL

  • Theophylline therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Theophylline Assay
Siemens Healthcare Diagnostics Inc.
10445324
In Commercial Distribution

  • 00842768001024 ()
4P019UL

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 N-Acetylprocainamide Calibrators
Siemens Healthcare Diagnostics Inc.
10445322
In Commercial Distribution

  • 00842768001017 ()
4N109UL

  • N-acetyl procainamide (NAPA) IVD, calibrator
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)
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
Theophylline Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445126
In Commercial Distribution

  • 00842768015458 ()
  • 00630414004976 ()
K4071

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445116
In Commercial Distribution

  • 00842768015441 ()
  • 00630414004891 ()
K5095

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Thyroxine Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445101
In Commercial Distribution

  • 00842768015434 ()
  • 00630414004754 ()
K6065

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Salicylate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445108
In Commercial Distribution

  • 00842768015427 ()
  • 00630414004815 ()
K5020

  • Salicylate IVD, kit, spectrophotometry
Phenytoin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445125
In Commercial Distribution

  • 00842768015410 ()
  • 00630414004969 ()
K4064

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Procainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445130
Not in Commercial Distribution

  • 00842768015403 ()
  • 00630414005010 ()
K4110

  • Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445124
In Commercial Distribution

  • 00842768015397 ()
  • 00630414004952 ()
K4060

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
Urine Phencyclidine Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445115
In Commercial Distribution

  • 00842768015380 ()
  • 00630414004884 ()
K5094

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
N-Acetyl Procainamide Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
10445131
Not in Commercial Distribution

  • 00842768015342 ()
  • 00630414005027 ()
K4111

  • N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Lactic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445153
In Commercial Distribution

  • 00842768015243 ()
  • 00630414005171 ()
K3016

  • Lactate IVD, kit, spectrophotometry
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