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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Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Cyclosporine Specific Assay
Siemens Healthcare Diagnostics Inc.
10445375
In Commercial Distribution

  • 00842768001451 ()
6R079UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Caffeine Control
Siemens Healthcare Diagnostics Inc.
10445372
In Commercial Distribution

  • 00842768001420 ()
6P499UL

  • Caffeine IVD, control
Syva® Emit® Caffeine Assay
Siemens Healthcare Diagnostics Inc.
10445371
In Commercial Distribution

  • 00842768001413 ()
6P419UL

  • Caffeine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Disopyramide Assay
Siemens Healthcare Diagnostics Inc.
10445370
In Commercial Distribution

  • 00842768001406 ()
6N319UL

  • Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Lidocaine Assay
Siemens Healthcare Diagnostics Inc.
10445369
In Commercial Distribution

  • 00842768001390 ()
6M119UL

  • Lidocaine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Methotrexate Assay
Siemens Healthcare Diagnostics Inc.
10445368
In Commercial Distribution

  • 00842768001383 ()
6L119UL

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Primidone Assay
Siemens Healthcare Diagnostics Inc.
10445366
In Commercial Distribution

  • 00842768001376 ()
6C119UL

  • Primidone therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
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