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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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Xprecia Stride™ Coagulation Analyzer - 00630414025148

The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.
Siemens Healthcare Diagnostics Inc.
11065584
In Commercial Distribution

  • 00630414025148 ()
11065584

  • Coagulation analyser IVD, point-of-care, battery-powered

ADVIA Centaur® AFP - 00630414022963

Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10998577
Not in Commercial Distribution

  • 00630414022963 ()
10998577

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

ADVIA 2120i wthout Autosampler - 00630414019796

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Siemens Healthcare Diagnostics Inc.
11219531
In Commercial Distribution

  • 00630414019796 ()
11219531

  • Haematological cell analyser IVD

ADVIA 2120i with SAA Autosampler - 00630414019789

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD

Atellica CH ASTPLc - 00630414009063

Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097639
In Commercial Distribution

  • 00630414009063 ()
11097639

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

Atellica CH ALTPLc - 00630414009056

Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

ADVIA® Chemistry Enzyme 3 Calibrator - 00630414008981

6 vials of 1 calibrator level
Siemens Healthcare Diagnostics Inc.
10916059
In Commercial Distribution

  • 00630414008981 ()
10916059

  • Total creatine kinase (CK) IVD, calibrator

ADVIA® Chemistry Enzyme 2 Calibrator - 00630414008974

Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL)
Siemens Healthcare Diagnostics Inc.
10916058
In Commercial Distribution

  • 00630414008974 ()
10916058

  • Multiple clinical chemistry enzyme IVD, calibrator

ADVIA® Chemistry Enzyme 1 Calibrator - 00630414008967

Enzyme 1 Calibrator - ADVIA Chemistry (ENZ 1 CAL)
Siemens Healthcare Diagnostics Inc.
10916057
In Commercial Distribution

  • 00630414008967 ()
10916057

  • Multiple clinical chemistry enzyme IVD, calibrator

ADVIA Chemistry P5PL_c Reagent - 00630414008950

ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc
Siemens Healthcare Diagnostics Inc.
10729782
In Commercial Distribution

  • 00630414306193 ()
  • 00630414008950 ()
10729782

  • Multiple clinical chemistry enzyme IVD, reagent
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