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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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
ALDL Calibrator, 2x3x2ml
Siemens Healthcare Diagnostics Inc.
10444996
In Commercial Distribution

  • 00842768014093 ()
  • 00630414017037 ()
DC131

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator
Cuvette Cartridge - Dimension® - 1 Cartridge
Siemens Healthcare Diagnostics Inc.
10445042
In Commercial Distribution

  • 00842768014086 ()
D828

  • Laboratory analyser cuvette IVD, single-use
Dimension® Sample Transfer Module Aliquot Segments
Siemens Healthcare Diagnostics Inc.
10445571
In Commercial Distribution

  • 00842768014048 ()
  • 00630414024547 ()
STM2

  • General specimen container IVD, no additive/medium
Dimension® Sample Transfer Module Pipette Tips
Siemens Healthcare Diagnostics Inc.
10445570
In Commercial Distribution

  • 00842768014031 ()
  • 00630414024530 ()
STM1

  • Pipette tip IVD
Quiklyte Diluent Check, 60mL
Siemens Healthcare Diagnostics Inc.
10444872
In Commercial Distribution

  • 00842768014024 ()
S640

  • Multiple electrolyte IVD, reagent
Sample Diluent, 6x500mL
Siemens Healthcare Diagnostics Inc.
10444874
In Commercial Distribution

  • 00842768014017 ()
  • 00630414003795 ()
S635

  • Multiple electrolyte IVD, reagent
QuikLYTE® Integrated Multisensor Standard B, 3x300mL
Siemens Healthcare Diagnostics Inc.
10444881
In Commercial Distribution

  • 00842768014000 ()
  • 00630414003818 ()
S625

  • Multiple electrolyte IVD, calibrator
QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter
Siemens Healthcare Diagnostics Inc.
10444878
In Commercial Distribution

  • 00842768013997 ()
  • 00630414003801 ()
S620

  • Multiple electrolyte IVD, calibrator
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