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® 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 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® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels
Siemens Healthcare Diagnostics Inc.
10445390
In Commercial Distribution

  • 00842768014321 ()
7C219UL

  • Multiple drugs of abuse IVD, calibrator
Y-Glutamyl Transferase Flex® reagent cartridge, 288 (4x72) tests
Siemens Healthcare Diagnostics Inc.
10444960
In Commercial Distribution

  • 00842768014154 ()
  • 00630414004433 ()
DF45A

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Reagent Probe Cleaner, 1x500mL
Siemens Healthcare Diagnostics Inc.
10445036
In Commercial Distribution

  • 00842768013768 ()
RD702

  • Wash/cleaning solution IVD, automated/semi-automated system
Ferritin Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445017
In Commercial Distribution

  • 00842768013744 ()
  • 00630414017136 ()
RC440

  • Ferritin IVD, calibrator
Human Chorionic Gonadotropin Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445019
In Commercial Distribution

  • 00842768013737 ()
  • 00630414017150 ()
RC430

  • Total human chorionic gonadotropin IVD, calibrator
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