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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Urine Ecstasy Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444921
In Commercial Distribution

  • 00842768014710 ()
  • 00630414004075 ()
DF109

  • Amphetamine/methamphetamine group 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)
Uric Acid Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444967
In Commercial Distribution

  • 00842768014192 ()
  • 00630414004488 ()
DF77

  • Uric acid IVD, kit, spectrophotometry
Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444926
In Commercial Distribution

  • 00842768005817 ()
  • 00630414004129 ()
DF91B

  • Amphetamine-specific 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)
Enhanced Liver Fibrosis (ELF) QC Kit - Atellica IM - CLT 3 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995566
In Commercial Distribution

  • 00630414598901 ()
10995566

  • Multiple liver fibrosis marker IVD, control
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