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® Ethyl Alcohol Low Control
Siemens Healthcare Diagnostics Inc.
10445447
In Commercial Distribution

  • 00842768001987 ()
9K049UL

  • Ethanol (ETOH) IVD, control
Syva® Emit® Ethyl Alcohol Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445445
In Commercial Distribution

  • 00842768001970 ()
9K029UL

  • Ethanol (ETOH) IVD, calibrator
Syva® Emit® II Plus Phencyclidine Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445443
In Commercial Distribution

  • 00842768001963 ()
9J129UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Phencyclidine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445441
In Commercial Distribution

  • 00842768001956 ()
9J029UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
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)
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