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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® Progesterone (PRGE) - 00630414454528

Progesterone (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10333111
In Commercial Distribution

  • 00630414454528 ()
  • 00630414010687 ()
126345

  • Progesterone IVD, kit, chemiluminescent immunoassay

RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution - 00630414452319

RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution
Siemens Healthcare Diagnostics Inc.
10318630
In Commercial Distribution

  • 00630414452319 ()
3279837

  • Multiple blood gas analyte IVD, calibrator

Valve Module (unheated) - 00630414452142

Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer
Siemens Healthcare Diagnostics Inc.
10309056
In Commercial Distribution

  • 00630414452142 ()
3372381

  • Blood gas/haemoximetry analyser IVD, point-of-care

RAPIDChem® 700 Urine Diluent - 00630414452104

RAPIDChem® 700 Urine Diluent for in vitro use with Rapidchem® 700 systems. Contains: buffers & presevatives
Siemens Healthcare Diagnostics Inc.
10308995
In Commercial Distribution

  • 00630414452104 ()
938058

  • Buffered sample diluent IVD

RAPIDChem® 744 Daily Cleaner Kit - 00630414452098

RAPIDChem® 744 Daily Cleaner Kit, for in vitro diagnostics use with Rapidchem® 744 systems.
Siemens Healthcare Diagnostics Inc.
10309011
In Commercial Distribution

  • 00630414452098 ()
1331777

  • Wash/cleaning solution IVD, automated/semi-automated system

RAPIDChem® 700 RAPIDPoint® 340/350 Reference Sensor - 00630414451893

RAPIDChem® 700 RAPIDPoint® 340/350 Reference Sensor for in vitro diagnostics use with Rapidchem® 700, Rapidpoint ® 340/350 systems.
Siemens Healthcare Diagnostics Inc.
10309034
In Commercial Distribution

  • 00630414451893 ()
2283180

  • Reference electrode IVD

RAPIDChem® 700 Chloride Sensor - 00630414451855

RAPIDChem® 700 Chloride Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
Siemens Healthcare Diagnostics Inc.
10308989
In Commercial Distribution

  • 00630414451855 ()
661439

  • Chloride (Cl-) electrode IVD

ADVIA Centaur® Systems, ACS:180® Systems cPSA 1,2,3 QC - 00630414451732

Complexed Prostate-specific Antigen (cPSA) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10310387
In Commercial Distribution

  • 00630414451732 ()
125425

  • Complexed prostate specific antigen (cPSA) IVD, control

ADVIA Centaur® FOL Ascorbic Acid Diluent DIL - 00630414451077

Ascorbic Acid - CENTAUR - CAL - 4x30mL
Siemens Healthcare Diagnostics Inc.
10316877
In Commercial Distribution

  • 00630414451077 ()
124975

  • Folate (vitamin B9) IVD, reagent

ADVIA Centaur® FOL DTT/Releasing Agent - 00630414451060

Folate DTT/REL AGT - CENTAUR - CONS - 600 Best.
Siemens Healthcare Diagnostics Inc.
10310382
In Commercial Distribution

  • 00630414451060 ()
124974

  • Dithiothriotol (DTT) reagent IVD
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