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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® 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® 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® 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
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