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® 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
Magnesium Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444963
In Commercial Distribution

  • 00842768014185 ()
  • 00630414004457 ()
DF57

  • Magnesium (Mg2+) IVD, kit, spectrophotometry
Pseudocholinesterase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444964
In Commercial Distribution

  • 00842768014178 ()
  • 00630414004464 ()
DF51

  • Pseudocholinesterase IVD, kit, spectrophotometry
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
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
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