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 Class Implantable

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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
Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
10311124
In Commercial Distribution

  • 00630414373201 ()
  • 00630414009315 ()
5019

  • Multiple urine analyte IVD, control
Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System.
Siemens Healthcare Diagnostics Inc.
10311123
In Commercial Distribution

  • 00630414373027 ()
5018A

  • Multiple urine analyte IVD, control
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