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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 Phencyclidine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445442
In Commercial Distribution

  • 00842768014406 ()
9J039UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cocaine Metabolite Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445438
In Commercial Distribution

  • 00842768014390 ()
9H039UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Syva® Emit® II Plus Propoxyphene Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445434
In Commercial Distribution

  • 00842768014383 ()
9G039UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Benzodiazepine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445430
In Commercial Distribution

  • 00842768014376 ()
9F039UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methadone Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445427
In Commercial Distribution

  • 00842768014369 ()
9E039UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445423
In Commercial Distribution

  • 00842768014352 ()
9D039UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Amphetamines Assay - 29 mL kit
Siemens Healthcare Diagnostics Inc.
10445418
In Commercial Distribution

  • 00842768014345 ()
9C039UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Opiate Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445414
In Commercial Distribution

  • 00842768014338 ()
9B039UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels
Siemens Healthcare Diagnostics Inc.
10445390
In Commercial Distribution

  • 00842768014321 ()
7C219UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® tox Serum Tricyclic Antidepressants Assay
Siemens Healthcare Diagnostics Inc.
10445389
In Commercial Distribution

  • 00842768014314 ()
7C209UL

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)
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