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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 Centaur® Systems VitD Calibrator - 00630414587882

Vitamin D - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10630911
In Commercial Distribution

  • 00630414587882 ()
10630911

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator

ADVIA Centaur® aTPO +0 - 00630414587844

TPO Ab - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10630887
In Commercial Distribution

  • 00630414587844 ()
  • 00630414005911 ()
10630887

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® aTPO - 00630414587837

TPO Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10630886
In Commercial Distribution

  • 00630414587837 ()
10630886

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® iPTH Calibrator - 00630414587486

PTH intact - CENTAUR - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

ADVIA Centaur CMV IgG QC - 00630414587448

CMV IgG ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10630613
In Commercial Distribution

  • 00630414587448 ()
  • 00630414224138 ()
10630613

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

VERSANT® Sample Preparation 1.2 Reagents (Box 2) - 00630414587141

VERSANT® Sample Preparation 1.2 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10629801
Not in Commercial Distribution

  • 00630414587141 ()
10629801

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Sample Preparation 1.2 Reagents (Box 1) - 00630414587134

VERSANT® Sample Preparation 1.2 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10629800
Not in Commercial Distribution

  • 00630414587134 ()
10629800

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® Systems VitD Calibrator - 00630414585093

Vitamin D - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10493589
In Commercial Distribution

  • 00630414585093 ()
10493589

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator

ADVIA® 2120i Hematology System - 00630414582047

ADVIA®2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10285572
In Commercial Distribution

  • 00630414582047 ()
067-A021-01

  • Haematological cell analyser IVD

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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