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® Emit® tox Serum Benzodiazepine Assay
Siemens Healthcare Diagnostics Inc.
10445388
In Commercial Distribution

  • 00842768001581 ()
7B119UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Serum Calibrators
Siemens Healthcare Diagnostics Inc.
10445387
In Commercial Distribution

  • 00842768001574 ()
7B019UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® tox Acetaminophen Calibrators
Siemens Healthcare Diagnostics Inc.
10445386
In Commercial Distribution

  • 00842768001567 ()
7A409UL

  • Acetaminophen IVD, calibrator
Syva® Emit® tox Acetaminophen Assay
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Cyclosporine Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10445378
In Commercial Distribution

  • 00842768001482 ()
  • 00630414010533 ()
6R719UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
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
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