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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® Emit® Ethyl Alcohol Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445445
In Commercial Distribution

  • 00842768001970 ()
9K029UL

  • Ethanol (ETOH) IVD, calibrator
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 Cocaine Metabolite Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445437
In Commercial Distribution

  • 00842768001932 ()
9H029UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Syva® Emit® II Plus Propoxyphene Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445435
In Commercial Distribution

  • 00842768001925 ()
9G129UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Propoxyphene Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445433
In Commercial Distribution

  • 00842768001918 ()
9G029UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Benzodiazepine Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445431
In Commercial Distribution

  • 00842768001901 ()
9F129UL

  • Benzodiazepine group 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® II Plus Barbiturate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445424
In Commercial Distribution

  • 00842768001888 ()
9D129UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445422
In Commercial Distribution

  • 00842768001871 ()
9D029UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Amphetamines Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445421
In Commercial Distribution

  • 00842768001864 ()
9C329UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
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