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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Cholesterol Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445143
In Commercial Distribution

  • 00842768015090 ()
  • 00630414005102 ()
K1027

  • Total cholesterol lipid IVD, kit, spectrophotometry
Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445118
In Commercial Distribution

  • 00842768015083 ()
  • 00630414004914 ()
K5097

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methaqualone Assay, 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445474
In Commercial Distribution

  • 00842768014437 ()
9Q039UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445470
In Commercial Distribution

  • 00842768014420 ()
9N039UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445446
In Commercial Distribution

  • 00842768014413 ()
9K039UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry
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)
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