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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® eE2 DIL - 00630414575100

Enhanced Estradiol 2 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10491878
In Commercial Distribution

  • 00630414575100 ()
  • 00630414005867 ()
10491878

  • Buffered sample diluent IVD

ADVIA® 120 Hematology System - 00630414575025

ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360959
In Commercial Distribution

  • 00630414575025 ()
067-A004-14

  • Haematological cell analyser IVD

ADVIA® 120 Hematology System - 00630414574868

ADVIA 120 Hematology System
Siemens Healthcare Diagnostics Inc.
10360958
In Commercial Distribution

  • 00630414574868 ()
067-A004-13

  • Haematological cell analyser IVD

ADVIA Centaur® eE2 - 00630414574646

Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10491445
In Commercial Distribution

  • 00630414574646 ()
10491445

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

CLINITEK Status®+ Analyzer - 00630414574639

The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379675
In Commercial Distribution

  • 00630414574639 ()
10379675

  • Urine analyser IVD, point-of-care

ADVIA® Chemistry Hemoglobin A1c_3 Calibrators - 00630414574516

HbA1C Kit - ADVIA Chem. - CAL - 2x4x0,5mL
Siemens Healthcare Diagnostics Inc.
10491408
Not in Commercial Distribution

  • 00630414574516 ()
10491408

  • Glycated haemoglobin (HbA1c) IVD, calibrator

ADVIA Centaur® CA 19-9™ - 00630414574257

CA 19-9 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10491379
In Commercial Distribution

  • 00630414574257 ()
10491379

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 19-9™ - 00630414574028

CA 19-9 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10491244
In Commercial Distribution

  • 00630414574028 ()
10491244

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® XP Analyzer - 00630414573564

ADVIA® CENTAUR® XP Instrument
Siemens Healthcare Diagnostics Inc.
10364455
In Commercial Distribution

  • 00630414573564 ()
078-A011-03

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® eE2 - 00630414573342

Estradiol - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10490889
In Commercial Distribution

  • 00630414573342 ()
10490889

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
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