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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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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
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems.
Siemens Healthcare Diagnostics Inc.
10309082
In Commercial Distribution

  • 00630414452289 ()
4955798

  • Potassium (K+) electrode IVD
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
Cl- Sensor module an in vitro diagnostics device to be used on the RAPIDChem® 744 analyzer
Siemens Healthcare Diagnostics Inc.
10309086
In Commercial Distribution

  • 00630414452135 ()
5453710

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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, 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
Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems.
Siemens Healthcare Diagnostics Inc.
10317312
In Commercial Distribution

  • 00630414452074 ()
2577729

  • Blood gas/haemoximetry analyser IVD, point-of-care
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 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
Siemens Healthcare Diagnostics Inc.
10308981
In Commercial Distribution

  • 00630414451862 ()
583772

  • Lithium electrode IVD
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
RAPIDChem® 700 RAPIDPoint® 350 Na+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint® 350 systems.
Siemens Healthcare Diagnostics Inc.
10309075
In Commercial Distribution

  • 00630414451848 ()
4473866

  • Sodium (Na+) electrode IVD
RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems.
Siemens Healthcare Diagnostics Inc.
10309093
In Commercial Distribution

  • 00630414451824 ()
5840552

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDChem® 744 Na+K+Cl- Reagent Module for in vitro diagnostics use with the Rapidchem® 744 system.
Siemens Healthcare Diagnostics Inc.
10309048
In Commercial Distribution

  • 00630414451817 ()
2970609

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Folate BA Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310389
In Commercial Distribution

  • 00630414451787 ()
  • 00630414003344 ()
125500

  • Buffered sample diluent IVD
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
Complexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack
Siemens Healthcare Diagnostics Inc.
10310384
In Commercial Distribution

  • 00630414451558 ()
125308

  • Complexed prostate specific antigen (cPSA) IVD, reagent
Probe Wash - CENTAUR - CONS - 1x250 Best.
Siemens Healthcare Diagnostics Inc.
10310358
In Commercial Distribution

  • 00630414451220 ()
123738

  • Buffered wash solution IVD
Calibrator Y - 2 pack (cPSA Cal)
Siemens Healthcare Diagnostics Inc.
10310383
In Commercial Distribution

  • 00630414451114 ()
125014

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Ascorbic Acid - CENTAUR - CAL - 4x30mL
Siemens Healthcare Diagnostics Inc.
10316877
In Commercial Distribution

  • 00630414451077 ()
124975

  • Folate (vitamin B9) IVD, reagent
Folate DTT/REL AGT - CENTAUR - CONS - 600 Best.
Siemens Healthcare Diagnostics Inc.
10310382
In Commercial Distribution

  • 00630414451060 ()
124974

  • Dithiothriotol (DTT) reagent IVD
Folic Acid - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10325366
In Commercial Distribution

  • 00630414450940 ()
124838

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Complexed Prostate-specific Antigen (cPSA) Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10310381
In Commercial Distribution

  • 00630414450896 ()
124830

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay
Complexed Prostate-specific Antigen (cPSA) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10310380
In Commercial Distribution

  • 00630414450872 ()
124828

  • Complexed prostate specific antigen (cPSA) IVD, control
CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control
RAPIDPoint® 400/405/500 Wash/Waste Cartridge is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 400/405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10310310
In Commercial Distribution

  • 00630414444581 ()
  • 00630414009223 ()
118677

  • Wash/cleaning solution IVD, automated/semi-automated system
RAPIDPoint® 400 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct for in vitro diagnostic use with RAPIDPoint® 400 systems.
Siemens Healthcare Diagnostics Inc.
10341161
In Commercial Distribution

  • 00630414443492 ()
118679

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 400/405/500 Wash/Waste Cartridge for in vitro diagnostics use with the RAPIDPoint® 400/405/500 series systems.
Siemens Healthcare Diagnostics Inc.
10341179
In Commercial Distribution

  • 00630414443485 ()
118678

  • Wash/cleaning solution IVD, automated/semi-automated system
Vancomycin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10323243
Not in Commercial Distribution

  • 00630414443096 ()
  • 00630414011165 ()
121197

  • Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Vitamin B12 RA Kit - CENTAUR - CONS - 1 Kit
Siemens Healthcare Diagnostics Inc.
10310330
In Commercial Distribution

  • 00630414443010 ()
121093

  • Vitamin B12 IVD, reagent
Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
10311135
In Commercial Distribution

  • 00630414374109 ()
  • 00630414009322 ()
5037

  • Multiple urine analyte IVD, control
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