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® 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.® 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.® 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
Siemens Healthcare Diagnostics Inc.
10445337
In Commercial Distribution

  • 00842768001116 ()
4W109UL

  • Vancomycin therapeutic drug monitoring IVD, calibrator
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
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