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 ® Ethyl Alcohol 100 mg/dL Calibrator
Siemens Healthcare Diagnostics Inc.
10445448
In Commercial Distribution

  • 00842768001994 ()
9K059UL

  • Ethanol (ETOH) IVD, calibrator
Syva® Emit® II Plus Phencyclidine Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445443
In Commercial Distribution

  • 00842768001963 ()
9J129UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cocaine Metabolite Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445439
In Commercial Distribution

  • 00842768001949 ()
9H129UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Syva® Emit® II Plus Benzodiazepine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445429
In Commercial Distribution

  • 00842768001895 ()
9F029UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Caffeine Assay
Siemens Healthcare Diagnostics Inc.
10445371
In Commercial Distribution

  • 00842768001413 ()
6P419UL

  • Caffeine IVD, kit, enzyme immunoassay (EIA)
Syva® RapidTest d.a.u.® BZO, Benzodiazepines
Siemens Healthcare Diagnostics Inc.
10445365
In Commercial Distribution

  • 00842768001369 ()
  • 00630414027401 ()
6A449UL

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Siemens Healthcare Diagnostics Inc.
10445363
In Commercial Distribution

  • 00842768001345 ()
  • 00630414013978 ()
6A289UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 8 THC / OPI / COC / mAMP / BZO / BAR / TCA / PCP
Siemens Healthcare Diagnostics Inc.
10445361
Not in Commercial Distribution

  • 00842768001321 ()
  • 00630414013954 ()
6A269UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Siemens Healthcare Diagnostics Inc.
10445360
In Commercial Distribution

  • 00842768001314 ()
  • 00630414013947 ()
6A259UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Siemens Healthcare Diagnostics Inc.
10445359
In Commercial Distribution

  • 00842768001307 ()
  • 00630414013923 ()
6A199UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest™ Tricyclic Antidepressants TCA
Siemens Healthcare Diagnostics Inc.
10445355
In Commercial Distribution

  • 00842768001277 ()
  • 00630414013879 ()
6A119UL

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
Syva® Emit® Antiepileptic Drug Calibrators
Siemens Healthcare Diagnostics Inc.
10445353
In Commercial Distribution

  • 00842768001253 ()
6A089UL

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Syva® RapidTest d.a.u.® Amphetamines AMP
Siemens Healthcare Diagnostics Inc.
10445350
In Commercial Distribution

  • 00842768001222 ()
  • 00630414013831 ()
6A059UL

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Methamphetamine mAMP
Siemens Healthcare Diagnostics Inc.
10445348
In Commercial Distribution

  • 00842768001208 ()
  • 00630414013817 ()
6A039UL

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Cocaine COC
Siemens Healthcare Diagnostics Inc.
10445346
In Commercial Distribution

  • 00842768001185 ()
  • 00630414013794 ()
6A019UL

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Syva® Emit® 2000 Vancomycin Assay
Siemens Healthcare Diagnostics Inc.
10445336
In Commercial Distribution

  • 00842768001109 ()
4W019UL

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 Gentamicin Plus Calibrators
Siemens Healthcare Diagnostics Inc.
10445334
In Commercial Distribution

  • 00842768001093 ()
4T209UL

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Gentamicin Plus Assay
Siemens Healthcare Diagnostics Inc.
10445333
In Commercial Distribution

  • 00842768001086 ()
4T039UL

  • Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Tobramycin Calibrators
Siemens Healthcare Diagnostics Inc.
10445331
In Commercial Distribution

  • 00842768001079 ()
4S109UL

  • Tobramycin therapeutic drug monitoring IVD, calibrator
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
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