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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)

Dimension® Flex® reagent cartridge IGA - 00842768005688

Immunoglobulin A Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444982
In Commercial Distribution

  • 00842768005688 ()
  • 00630414004587 ()
DF74

  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge TP - 00842768005671

Total Protein Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444979
In Commercial Distribution

  • 00842768005671 ()
  • 00630414004556 ()
DF73

  • Total protein IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge THEO - 00842768005664

Theophylline Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444942
In Commercial Distribution

  • 00842768005664 ()
  • 00630414004297 ()
DF71

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

Dimension® Flex® reagent cartridge TRIG - 00842768005657

Triglycerides Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444906
In Commercial Distribution

  • 00842768005657 ()
  • 00630414003948 ()
DF69A

  • Triglyceride IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge PTN - 00842768005619

Phenytoin Flex® reagent cartridge, 112 tests
Siemens Healthcare Diagnostics Inc.
10444940
In Commercial Distribution

  • 00842768005619 ()
  • 00630414004273 ()
DF64

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

Dimension® Flex® reagent cartridge PHNO - 00842768005596

Phenobarbital Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444933
In Commercial Distribution

  • 00842768005596 ()
  • 00630414004181 ()
DF60

  • Phenobarbital IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge AST - 00842768005558

Aspartate Aminotransferase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10444959
In Commercial Distribution

  • 00842768005558 ()
  • 00630414004426 ()
DF41A

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge MALB - 00842768005312

Microalbumin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444977
In Commercial Distribution

  • 00842768005312 ()
  • 00630414004532 ()
DF114

  • Microalbumin IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge LIDO - 00842768005305

Lidocaine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444935
In Commercial Distribution

  • 00842768005305 ()
  • 00630414004211 ()
DF113

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

Dimension® Flex® reagent cartridge PROC - 00842768005282

Procainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444937
In Commercial Distribution

  • 00842768005282 ()
  • 00630414004242 ()
DF110

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

Dimension® Flex® reagent cartridge ACP - 00842768005275

Acid Phosphatase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444948
Not in Commercial Distribution

  • 00842768005275 ()
  • 00630414004341 ()
DF11

  • Prostatic acid phosphatase (PAP) IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge CSAE - 00842768005268

Cyclosporine Extended Range Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444934
Not in Commercial Distribution

  • 00842768005268 ()
  • 00630414004198 ()
DF108

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge TRNF - 00842768005244

Transferrin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444985
In Commercial Distribution

  • 00842768005244 ()
  • 00630414004617 ()
DF103

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge C4 - 00842768005237

Complement C4 Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444981
In Commercial Distribution

  • 00842768005237 ()
  • 00630414004570 ()
DF102

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge C3 - 00842768005220

Complement C3 Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444980
In Commercial Distribution

  • 00842768005220 ()
  • 00630414004563 ()
DF101

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Dimension® CSA Calibrator - 00842768005213

Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® IBCT Calibrator - 00842768005206

IBCT (Total Iron Binding Protein) Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10445006
In Commercial Distribution

  • 00842768005206 ()
  • 00630414017099 ()
DC84

  • Total iron binding capacity (TIBC) IVD, calibrator

Dimension® Special Protein Calibrator - 00842768005190

Special Protein Calibrator, 2x5x1.5mL
Siemens Healthcare Diagnostics Inc.
10445028
In Commercial Distribution

  • 00842768005190 ()
  • 00630414017211 ()
DC51

  • Multiple clinical chemistry protein IVD, calibrator

Dimension® PALB Calibrator - 00842768005183

Prealbumin Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445025
In Commercial Distribution

  • 00842768005183 ()
  • 00630414017198 ()
DC50

  • Prealbumin (transthyretin) IVD, calibrator

Dimension® UCFP Calibrator - 00842768005152

Urinary / Cerebrospinal Fluid Protein Calibrator, 2x5x4mL
Siemens Healthcare Diagnostics Inc.
10444989
In Commercial Distribution

  • 00842768005152 ()
  • 00630414016986 ()
DC45

  • Total protein IVD, calibrator
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