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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 Vista® MYO CAL - 00842768016509

Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator

Dimension Vista® EXTC CAL - 00842768016486

Ecstasy Calibrator, 3x2x2.3mL
Siemens Healthcare Diagnostics Inc.
10445188
In Commercial Distribution

  • 00842768016486 ()
KC520

  • Amphetamine/methamphetamine group IVD, calibrator

Dimension Vista® UDAT CON (-) - 00842768016479

Drugs of Abuse Negative Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445199
In Commercial Distribution

  • 00842768016479 ()
  • 00630414005294 ()
KC516

  • Multiple drugs of abuse IVD, control

Dimension Vista® UDAT CON (+) - 00842768016462

Drugs of Abuse Positive Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445198
In Commercial Distribution

  • 00842768016462 ()
  • 00630414005287 ()
KC515

  • Multiple drugs of abuse IVD, control

Dimension Vista® UDAT CAL - 00842768016455

Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL
Siemens Healthcare Diagnostics Inc.
10445187
In Commercial Distribution

  • 00842768016455 ()
KC510

  • Multiple drugs of abuse IVD, calibrator

Dimension Vista® CSAE CAL - 00842768016448

Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension Vista® UCFP CAL - 00842768016431

Urinary/Cerebrospinal Fluid Protein Calibrator, 3x1.5mL
Siemens Healthcare Diagnostics Inc.
10445178
In Commercial Distribution

  • 00842768016431 ()
KC260

  • Total protein IVD, calibrator

Dimension Vista® Sample Proble Cleaner 7 - 00842768016356

Sample Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445209
In Commercial Distribution

  • 00842768016356 ()
  • 00630414005386 ()
KS807

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension Vista® Reagent Probe Cleaner 6 - 00842768016349

Reagent Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445208
In Commercial Distribution

  • 00842768016349 ()
  • 00630414005379 ()
KS806

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension Vista® Cuvette Wash Solution 5 - 00842768016332

Cuvette wash solution, 2 x 2.4 L
Siemens Healthcare Diagnostics Inc.
10445207
In Commercial Distribution

  • 00842768016332 ()
  • 00630414005362 ()
KS805

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension Vista® System Diluent 4 - 00842768016325

Dimension Vista® System Diluent, 2x1.5 L
Siemens Healthcare Diagnostics Inc.
10445206
In Commercial Distribution

  • 00842768016325 ()
  • 00630414005355 ()
KS804

  • Buffered sample diluent IVD

Dimension Vista® Empty Vials Kit - 00842768016295

Empty Vials Kit, 357 Vials, 375 Caps, 3 X 550 Labels
Siemens Healthcare Diagnostics Inc.
10445213
In Commercial Distribution

  • 00842768016295 ()
KS865

  • Assay container IVD, single-use

Dimension Vista® LOCI® Reaction Vessels - 00842768016288

LOCI® Reaction Vessel, 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10445212
In Commercial Distribution

  • 00842768016288 ()
  • 00630414005416 ()
KS855

  • Assay container IVD, single-use

Dimension Vista® Cuvettes - 00842768016271

Cuvettes, 20x240 (4800)
Siemens Healthcare Diagnostics Inc.
10445211
In Commercial Distribution

  • 00842768016271 ()
  • 00630414005409 ()
KS850

  • Laboratory analyser cuvette IVD, single-use

Dimension Vista® Aliquot Plates - 00842768016264

Aliquot Plates, 30x12 (360)
Siemens Healthcare Diagnostics Inc.
10445210
In Commercial Distribution

  • 00842768016264 ()
  • 00630414005393 ()
KS840

  • General specimen container IVD, no additive/medium

Dimension Vista® V-LTYE® Dilution Check - 00842768016257

V-LYTE® Dilution Check, 6x2mL
Siemens Healthcare Diagnostics Inc.
10445203
In Commercial Distribution

  • 00842768016257 ()
  • 00630414005331 ()
K840

  • Multiple electrolyte IVD, reagent

Dimension Vista® V-LTYE® Diluent 3 - 00842768016240

V-LYTE® Diluent, 2x1.5 L
Siemens Healthcare Diagnostics Inc.
10445202
In Commercial Distribution

  • 00842768016240 ()
  • 00630414005324 ()
K835

  • Buffered sample diluent IVD

Dimension Vista® V-LTYE® Standard B V-LYTE® Salt Bridge 1 - 00842768016233

V-LYTE Standard B/Salt Bridge, 2x125mL
Siemens Healthcare Diagnostics Inc.
10445201
In Commercial Distribution

  • 00842768016233 ()
  • 00630414005317 ()
K825

  • Multiple electrolyte IVD, calibrator

Dimension Vista® V-LTYE® Standard A 2 - 00842768016226

V-LYTE® Standard A, 2x1.5 L
Siemens Healthcare Diagnostics Inc.
10445200
In Commercial Distribution

  • 00842768016226 ()
  • 00630414005300 ()
K820

  • Multiple electrolyte IVD, calibrator

Dimension Vista® Flex® reagent cartridge CSAE - 00842768016035

Cyclosporine Extended Range Flex® reagent cartridge, 60 Tests
Siemens Healthcare Diagnostics Inc.
10445142
Not in Commercial Distribution

  • 00842768016035 ()
  • 00630414005096 ()
K4108

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

Dimension CardioPhase high sensitivity CRP Flex reagent cartridge - 00842768016028

CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444897
In Commercial Distribution

  • 00842768016028 ()
  • 00630414003887 ()
RF434

  • C-reactive protein (CRP) IVD, kit, spectrophotometry

Dimension® CCRP Calibrator - 00842768016011

CardioPhase® hsCRP Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445003
In Commercial Distribution

  • 00842768016011 ()
  • 00630414017068 ()
RC434

  • C-reactive protein (CRP) IVD, calibrator

Dimension Vista®/Dimension® EXL™ CTNI SDIL - 00842768015892

CTNI Sample Diluent, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445205
In Commercial Distribution

  • 00842768015892 ()
  • 00630414005348 ()
KD692

  • Buffered sample diluent IVD

Dimension Vista® ENZ 1 CAL - 00842768015861

Enzyme 1 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL)
Siemens Healthcare Diagnostics Inc.
10445179
In Commercial Distribution

  • 00842768015861 ()
KC310

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension Vista® IRON CAL - 00842768015854

Iron Calibrator, 3x1.2mL
Siemens Healthcare Diagnostics Inc.
10445176
In Commercial Distribution

  • 00842768015854 ()
KC240

  • Iron IVD, calibrator

Dimension Vista® TIBC CAL - 00842768015847

Total Iron Binding Capacity Calibrator, 3x1mL
Siemens Healthcare Diagnostics Inc.
10445175
In Commercial Distribution

  • 00842768015847 ()
KC230

  • Total iron binding capacity (TIBC) IVD, calibrator

Dimension Vista® BILI CAL - 00842768015823

Bilirubin Calibrator, 3x2.5 mL
Siemens Healthcare Diagnostics Inc.
10460279
In Commercial Distribution

  • 00842768015823 ()
KC210

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 4 CAL - 00842768015816

Chemistry 4 Calibrator, 3 (3A x 1.5 mL)
Siemens Healthcare Diagnostics Inc.
10445172
In Commercial Distribution

  • 00842768015816 ()
KC140

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 2 CAL - 00842768015793

Chemistry 2 Calibrator, 6 (3A x 2.0 mL; 3B x 2.0 mL)
Siemens Healthcare Diagnostics Inc.
10445170
In Commercial Distribution

  • 00842768015793 ()
KC120

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® DRUG 2 CAL - 00842768015779

Drug 2 Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10445184
In Commercial Distribution

  • 00842768015779 ()
KC420

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

Dimension Vista® DRUG 1 CAL - 00842768015762

Drug 1 Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10445183
In Commercial Distribution

  • 00842768015762 ()
KC410

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

Dimension Vista® Flex® reagent cartridge TSH - 00842768015731

Thyroid Stimulating Hormone Flex® reagent cartridge, 960 Tests
Siemens Healthcare Diagnostics Inc.
10445104
In Commercial Distribution

  • 00842768015731 ()
  • 00630414004785 ()
K6412

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge TP - 00842768015724

Total Protein Flex® reagent cartridge, 1560 tests
Siemens Healthcare Diagnostics Inc.
10445167
In Commercial Distribution

  • 00842768015724 ()
  • 00630414005263 ()
K1073

  • Total protein IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge TBIL - 00842768015717

Total Bilirubin Flex® reagent cartridge, 640 Tests
Siemens Healthcare Diagnostics Inc.
10445146
In Commercial Distribution

  • 00842768015717 ()
  • 00630414005133 ()
K1167

  • Total bilirubin IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge PHOS - 00842768015700

Phosphorus Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445144
In Commercial Distribution

  • 00842768015700 ()
  • 00630414005119 ()
K1061

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge MG - 00842768015694

Magnesium Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445158
In Commercial Distribution

  • 00842768015694 ()
  • 00630414005201 ()
K3057

  • Magnesium (Mg2+) IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge GLU - 00842768015663

Glucose Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10445162
In Commercial Distribution

  • 00842768015663 ()
  • 00630414005232 ()
K1039

  • Glucose IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge EMPTY - 00842768015656

EMPTY Flex® reagent cartridge, 4 Flex® reagent cartridges
Siemens Healthcare Diagnostics Inc.
10445218
In Commercial Distribution

  • 00842768015656 ()
  • 00630414005423 ()
KS999

  • Assay container IVD, single-use

Dimension Vista® Flex® reagent cartridge DBIL - 00842768015649

Direct Bilirubin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10445152
In Commercial Distribution

  • 00842768015649 ()
  • 00630414005164 ()
K2125

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge CO2 - 00842768015625

Carbon Dioxide Flex® reagent cartridge, 3360 Tests
Siemens Healthcare Diagnostics Inc.
10445163
In Commercial Distribution

  • 00842768015625 ()
  • 00630414005249 ()
K1137

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
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