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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 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)
Flush Solution, 3x1000mL
Siemens Healthcare Diagnostics Inc.
10445051
In Commercial Distribution

  • 00842768014307 ()
  • 00630414004686 ()
S630

  • Multiple electrolyte IVD, reagent
QuikLYTE® Integrated Multisensor
Siemens Healthcare Diagnostics Inc.
10445058
In Commercial Distribution

  • 00842768014291 ()
  • 00630414004693 ()
S600

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Chemistry Wash, 1x1.7 L
Siemens Healthcare Diagnostics Inc.
10445052
In Commercial Distribution

  • 00842768014277 ()
RD701

  • Wash/cleaning solution IVD, automated/semi-automated system
Uric Acid Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444967
In Commercial Distribution

  • 00842768014192 ()
  • 00630414004488 ()
DF77

  • Uric acid IVD, kit, spectrophotometry
C-Reactive Protein Extended Range Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444903
In Commercial Distribution

  • 00842768014130 ()
  • 00630414003917 ()
DF34

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Calcium Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444949
In Commercial Distribution

  • 00842768014123 ()
  • 00630414004358 ()
DF23A

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Urea Nitrogen Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444969
In Commercial Distribution

  • 00842768014116 ()
  • 00630414004495 ()
DF21

  • Urea IVD, kit, enzyme spectrophotometry
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