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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® MYO Calibrator - 00842768013720

Myoglobin Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445024
In Commercial Distribution

  • 00842768013720 ()
  • 00630414017181 ()
RC422

  • Myoglobin IVD, calibrator

Dimension® CTNI Calibrator - 00842768013713

Cardiac Troponin-I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10444986
In Commercial Distribution

  • 00842768013713 ()
  • 00630414016955 ()
RC421C

  • Troponin I IVD, calibrator

Dimension® MMB Calibrator - 00842768013706

Mass Creatine Kinase MB Isoenzyme Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445023
In Commercial Distribution

  • 00842768013706 ()
  • 00630414017174 ()
RC420

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Dimension® Thyroid Calibrator - 00842768013683

Thyroid Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445018
In Commercial Distribution

  • 00842768013683 ()
  • 00630414017143 ()
RC410

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension® Flex® reagent cartridge VANC - 00842768005763

Vancomycin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444929
In Commercial Distribution

  • 00842768005763 ()
  • 00630414004150 ()
DF86

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge IGM - 00842768005732

Immunoglobulin M Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444984
In Commercial Distribution

  • 00842768005732 ()
  • 00630414004600 ()
DF81

  • Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge PALB - 00842768005725

Prealbumin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444978
In Commercial Distribution

  • 00842768005725 ()
  • 00630414004549 ()
DF80

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge VALP - 00842768005718

Valproic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444943
In Commercial Distribution

  • 00842768005718 ()
  • 00630414004303 ()
DF78

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge IGG - 00842768005701

Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge TU - 00842768005695

Thyronine Uptake Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444912
In Commercial Distribution

  • 00842768005695 ()
  • 00630414003993 ()
DF75A

  • Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)
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