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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® Chemistry sBNZ Serum Benzodiazepine Reagents - 00630414526928

Benzodiazepines - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10335939
Not in Commercial Distribution

  • 00630414526928 ()
5042192

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry METMTB Methadone Metabolite Reagents - 00630414526904

TBD
Siemens Healthcare Diagnostics Inc.
10335933
Not in Commercial Distribution

  • 00630414526904 ()
5038055

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry ISE Buffer - 00630414526768

ISE Buffer Large - ADVIA Chem. - CONS - 3 Liter
Siemens Healthcare Diagnostics Inc.
10321715
In Commercial Distribution

  • 00630414526768 ()
4997873

  • pH-adjusted buffer solution IVD

ADVIA Centaur® Calibrator E - 00630414524733

(ECOR) - CENTAUR 180 - CAL E
Siemens Healthcare Diagnostics Inc.
10335532
In Commercial Distribution

  • 00630414524733 ()
4636889

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E - 00630414524726

Cortisol (6PK) - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10321075
In Commercial Distribution

  • 00630414524726 ()
4634762

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® Systems ACS:180® Systems Calibrator E - 00630414524719

Cortisol (2PK) - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309079
In Commercial Distribution

  • 00630414524719 ()
4634452

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® CP Immunoassay System - 00630414523286

ADVIA® CENTAUR® CP Instrument
Siemens Healthcare Diagnostics Inc.
10309710
In Commercial Distribution

  • 00630414523286 ()
086-A002-01

  • Chemiluminescent immunoassay analyser IVD

ADVIA Autoslide® Slide Maker Stainer - 00630414517360

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10318817
In Commercial Distribution

  • 00630414517360 ()
085-A001-01

  • Microscope slide maker/stainer IVD

TB1 pO2/pCO2 Test/Blank Sensor - 00630414515250

Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10316620
In Commercial Distribution

  • 00630414515250 ()
2195443

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

MultiCap-S pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414511542

RAPIDLyte Multicap-S plastic blood collection capillary tubes (500 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/Li+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10316361
In Commercial Distribution

  • 00630414511542 ()
  • 00630414009438 ()
2043295

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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