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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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Dimension® Flex® reagent cartridge BUN - 00842768014116

Urea Nitrogen Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444969
In Commercial Distribution

  • 00842768014116 ()
  • 00630414004495 ()
DF21

  • Urea IVD, kit, enzyme spectrophotometry

Dimension® ALDL Calibrator - 00842768014093

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

  • 00842768014093 ()
  • 00630414017037 ()
DC131

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator

Dimension® Cuvette Cartridge - 00842768014086

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 - 00842768014048

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® Pipette Tips - 00842768014031

Dimension® Sample Transfer Module Pipette Tips
Siemens Healthcare Diagnostics Inc.
10445570
In Commercial Distribution

  • 00842768014031 ()
  • 00630414024530 ()
STM1

  • Pipette tip IVD

Dimension® QuikLYTE® Integrated Multisensor Sample Diluent - 00842768014017

Sample Diluent, 6x500mL
Siemens Healthcare Diagnostics Inc.
10444874
In Commercial Distribution

  • 00842768014017 ()
  • 00630414003795 ()
S635

  • Multiple electrolyte IVD, reagent

Dimension® Reaction Vessels - 00842768013928

Dimension® Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5)
Siemens Healthcare Diagnostics Inc.
10445044
In Commercial Distribution

  • 00842768013928 ()
RXV1A

  • Laboratory waste receptacle liner IVD

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge - 00842768013898

Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

Dimension® clinical chemistry system TPSA Flex® reagent cartridge - 00842768013874

Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444889
In Commercial Distribution

  • 00842768013874 ()
  • 00630414601762 ()
RF451

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge FERR - 00842768013867

Ferritin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444946
In Commercial Distribution

  • 00842768013867 ()
  • 00630414004334 ()
RF440

  • Ferritin IVD, kit, enzyme immunoassay (EIA)
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