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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 Human Chorionic Gonadotropin Flex reagent cartridge - 00842768013911

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444914
In Commercial Distribution

  • 00842768013911 ()
  • 00630414004013 ()
RF530

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013904

Cardiac Troponin-I Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10444896
In Commercial Distribution

  • 00842768013904 ()
  • 00630414003870 ()
RF521

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

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 FPSA Flex® reagent cartridge - 00842768013881

Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) 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)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG - 00842768013850

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444913
In Commercial Distribution

  • 00842768013850 ()
  • 00630414004006 ()
RF430

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO - 00842768013843

Myoglobin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444907
In Commercial Distribution

  • 00842768013843 ()
  • 00630414003955 ()
RF422A

  • Myoglobin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013836

Cardiac Troponin-I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444905
In Commercial Distribution

  • 00842768013836 ()
  • 00630414003931 ()
RF421C

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge - 00842768013829

Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

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

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH - 00842768013805

Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10444911
In Commercial Distribution

  • 00842768013805 ()
  • 00630414003986 ()
RF412

  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge FT4 - 00842768013799

Free Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444910
In Commercial Distribution

  • 00842768013799 ()
  • 00630414003979 ()
RF410

  • Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

Dimension® IMT Probe Cleaner - 00842768013782

IMT Probe Cleaner, 6x20mL
Siemens Healthcare Diagnostics Inc.
10445038
In Commercial Distribution

  • 00842768013782 ()
  • 00630414004648 ()
RD704

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

Dimension® Sample Probe Cleaner - 00842768013775

Sample Probe Cleaner, 1x1 Liter
Siemens Healthcare Diagnostics Inc.
10445035
In Commercial Distribution

  • 00842768013775 ()
RD703

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

Dimension® Reagent Probe Cleaner - 00842768013768

Reagent Probe Cleaner, 1x500mL
Siemens Healthcare Diagnostics Inc.
10445036
In Commercial Distribution

  • 00842768013768 ()
RD702

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

Dimension® clinical chemistry system T/F PSA Calibrator - 00842768013751

Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension® FERR Calibrator - 00842768013744

Ferritin Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445017
In Commercial Distribution

  • 00842768013744 ()
  • 00630414017136 ()
RC440

  • Ferritin IVD, calibrator

Dimension® HCG Calibrator - 00842768013737

Human Chorionic Gonadotropin Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445019
In Commercial Distribution

  • 00842768013737 ()
  • 00630414017150 ()
RC430

  • Total human chorionic gonadotropin IVD, calibrator

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 BARB - 00842768005862

Urine Barbiturates Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444918
In Commercial Distribution

  • 00842768005862 ()
  • 00630414004044 ()
DF96A

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge PCP - 00842768005848

Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444924
In Commercial Distribution

  • 00842768005848 ()
  • 00630414004105 ()
DF94A

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge COC - 00842768005824

Urine Cocaine Metabolite Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444920
In Commercial Distribution

  • 00842768005824 ()
  • 00630414004068 ()
DF92A

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Dimension® Flex® reagent cartridge METH - 00842768005800

Urine Methadone Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444922
In Commercial Distribution

  • 00842768005800 ()
  • 00630414004082 ()
DF90A

  • Methadone IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge CRBM - 00842768005770

Carbamazepine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444930
In Commercial Distribution

  • 00842768005770 ()
  • 00630414004167 ()
DF87

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

Dimension® Flex® reagent cartridge IBCT - 00842768005756

Total Iron Binding Capacity Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444944
In Commercial Distribution

  • 00842768005756 ()
  • 00630414004310 ()
DF84

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry

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 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 T4 - 00842768005626

Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444908
In Commercial Distribution

  • 00842768005626 ()
  • 00630414003962 ()
DF65

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)

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 GLUC - 00842768005541

Glucose Flex® reagent cartridge, 1440 tests
Siemens Healthcare Diagnostics Inc.
10444971
In Commercial Distribution

  • 00842768005541 ()
  • 00630414004501 ()
DF40

  • Glucose IVD, kit, spectrophotometry
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