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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® MYO - 00630414197180

Myoglobin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310277
In Commercial Distribution

  • 00630414197180 ()
117030

  • Myoglobin IVD, kit, chemiluminescent immunoassay

Calibrating Gas Kit - 00630414196701

Calibrating Gas Kit for Siemens Healthcare Diagnostics Blood Gas Systems that use gas regulators without metering valves.
Siemens Healthcare Diagnostics Inc.
10318934
In Commercial Distribution

  • 00630414196701 ()
116769

  • Multiple blood gas analyte IVD, calibrator

ADVIA Centaur® BR Pre - 00630414196688

BR Pretreatment - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310272
In Commercial Distribution

  • 00630414196688 ()
  • 00630414003290 ()
116746

  • Cancer antigen 27-29 (CA27-29) IVD, reagent

ADVIA Centaur® Systems, ACS:180® Systems Calibrator D - 00630414124940

Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10331182
In Commercial Distribution

  • 00630414124940 ()
672183005

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator D - 00630414124933

Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Calibrator C - 00630414124926

Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10334728
In Commercial Distribution

  • 00630414124926 ()
672182005

  • Multiple anaemia-related analyte IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems Calibrator C - 00630414124919

Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10311575
In Commercial Distribution

  • 00630414124919 ()
672182000

  • Multiple anaemia-related analyte IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator - 00630414124803

CK-MB - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311570
In Commercial Distribution

  • 00630414124803 ()
672174000

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

ADVIA Centaur® Calibrator D - 00630414124797

Calibrator D - 2 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311569
In Commercial Distribution

  • 00630414124797 ()
672173000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Calibrator C - 00630414124780

Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator
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