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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® 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)
Syva® Emit® II Plus Amphetamines Assay - 115 mL
Siemens Healthcare Diagnostics Inc.
10445420
In Commercial Distribution

  • 00842768001857 ()
9C309UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Opiate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445417
In Commercial Distribution

  • 00842768001826 ()
9B329UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Opiate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445416
In Commercial Distribution

  • 00842768001819 ()
9B309UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Calibrator B Level 2 (high)
Siemens Healthcare Diagnostics Inc.
10445413
In Commercial Distribution

  • 00842768001802 ()
9A899UL

  • Amphetamine/methamphetamine group IVD, calibrator
Syva® Emit® Calibrator B Level 1 (cutoff)
Siemens Healthcare Diagnostics Inc.
10445412
In Commercial Distribution

  • 00842768001796 ()
9A879UL

  • Amphetamine/methamphetamine group IVD, calibrator
Syva® Emit® Calibrator/Control Level 5
Siemens Healthcare Diagnostics Inc.
10445411
In Commercial Distribution

  • 00842768001789 ()
9A609UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10445410
In Commercial Distribution

  • 00842768001772 ()
9A589UL

  • Multiple drugs of abuse IVD, calibrator
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