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 Class Implantable

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Testosterone - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322623
Not in Commercial Distribution

  • 00630414454658 ()
  • 00630414010519 ()
125363

  • Total testosterone IVD, kit, chemiluminescent immunoassay
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
Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10311120
In Commercial Distribution

  • 00630414373003 ()
5017

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10311113
In Commercial Distribution

  • 00630414372464 ()
  • 00630414009308 ()
5007A

  • Buffered wash solution IVD
Clinitek Atlas® Calibrator #4 In vitro diagnostic medical device
Siemens Healthcare Diagnostics Inc.
10311106
In Commercial Distribution

  • 00630414372181 ()
5006

  • Multiple urine analyte IVD, control
No Description
Siemens Healthcare Diagnostics Inc.
11697146
In Commercial Distribution

  • 00630414317496 ()
11697146

  • Medical equipment clinical data interfacing software
No Description
Siemens Healthcare Diagnostics Inc.
11697145
In Commercial Distribution

  • 00630414317489 ()
11697145

  • Medical equipment clinical data interfacing software
No Description
Siemens Healthcare Diagnostics Inc.
11697144
In Commercial Distribution

  • 00630414317472 ()
11697144

  • Medical equipment clinical data interfacing software
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