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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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ADVIA® 2120i Hematology System - 00630414581965

ADVIA® 2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10488923
In Commercial Distribution

  • 00630414581965 ()
067-A014-01

  • Haematological cell analyser IVD

ADVIA Centaur® aTG MCM - 00630414580722

TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control

ADVIA Centaur® Testosterone 2 MCM - 00630414580654

Testosterone 2 Master Curve Material SET - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492623
In Commercial Distribution

  • 00630414580654 ()
10492623

  • Total testosterone IVD, control

ADVIA Centaur® Systems QC SYPH - 00630414580616

Syphillis - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10492616
In Commercial Distribution

  • 00630414580616 ()
10492616

  • Treponema pallidum total antibody IVD, control

ADVIA Centaur® SYPH - 00630414580173

Syphilis - CENTAUR - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10492493
In Commercial Distribution

  • 00630414580173 ()
10492493

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems Calibrator 80 - 00630414580111

IgE - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10492491
In Commercial Distribution

  • 00630414580111 ()
10492491

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator

ADVIA Centaur® Systems iPTH Calibrator - 00630414579207

PTH Intact - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10492394
In Commercial Distribution

  • 00630414579207 ()
10492394

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® Systems iPTH Calibrator - 00630414579191

PTH Intact - CENTAUR - CAL - 6x2x1mL
Siemens Healthcare Diagnostics Inc.
10492387
In Commercial Distribution

  • 00630414579191 ()
10492387

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® Systems QC iPTH - 00630414579184

PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control

ADVIA Centaur® iPTH MCM - 00630414579177

PTH Intact Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492373
In Commercial Distribution

  • 00630414579177 ()
10492373

  • Parathyroid hormone (PTH) IVD, control
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