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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® RapidTest d.a.u.® TCA - 00842768001277

Syva® RapidTest™ Tricyclic Antidepressants TCA
Siemens Healthcare Diagnostics Inc.
10445355
In Commercial Distribution

  • 00842768001277 ()
  • 00630414013879 ()
6A119UL

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Syva® RapidTest d.a.u.® MDN - 00842768001260

Syva® RapidTest d.a.u.® Methadone MDN
Siemens Healthcare Diagnostics Inc.
10445354
In Commercial Distribution

  • 00842768001260 ()
  • 00630414013862 ()
6A109UL

  • Methadone IVD, kit, rapid ICT, clinical

Syva® Emit® Antiepileptic Drug Calibrators - 00842768001253

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.® BAR - 00842768001246

Syva® RapidTest d.a.u.® Barbiturates BAR
Siemens Healthcare Diagnostics Inc.
10445352
In Commercial Distribution

  • 00842768001246 ()
  • 00630414013855 ()
6A079UL

  • Barbiturate IVD, kit, rapid ICT, clinical

Syva® RapidTest d.a.u.® AMP - 00842768001222

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.® OPI - 00842768001215

Syva® RapidTest d.a.u.® Opiates OPI
Siemens Healthcare Diagnostics Inc.
10445349
In Commercial Distribution

  • 00842768001215 ()
  • 00630414013824 ()
6A049UL

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Syva® RapidTest d.a.u.® mAMP - 00842768001208

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.® THC - 00842768001192

Syva® RapidTest d.a.u.® Cannabinoids THC
Siemens Healthcare Diagnostics Inc.
10445347
In Commercial Distribution

  • 00842768001192 ()
  • 00630414013800 ()
6A029UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Syva® RapidTest d.a.u.® COC - 00842768001185

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 Calibrators - 00842768001116

Syva® Emit® 2000 Vancomycin Calibrators
Siemens Healthcare Diagnostics Inc.
10445337
In Commercial Distribution

  • 00842768001116 ()
4W109UL

  • Vancomycin therapeutic drug monitoring IVD, calibrator
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