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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Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
Siemens Healthcare Diagnostics Inc.
11700159
In Commercial Distribution

  • 00630414321486 ()
  • 00630414652597 ()
11700159

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Atellica IM 1600 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764888
In Commercial Distribution

  • 00630414650623 ()
11066000

  • Chemiluminescent immunoassay analyser IVD
Atellica IM 1300 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764765
In Commercial Distribution

  • 00630414650579 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
RAPIDPOINT® 340/350 PCO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375797
In Commercial Distribution

  • 00630414566252 ()
10375797

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375796
In Commercial Distribution

  • 00630414566245 ()
10375796

  • Blood pH electrode
RAPIDPOINT® 340 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375809
In Commercial Distribution

  • 00630414566238 ()
10375809

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Trouble shooting kit for use with RAPIDPoint® 350 blood gas analyzers
Siemens Healthcare Diagnostics Inc.
10375803
In Commercial Distribution

  • 00630414566221 ()
10375803

  • Blood gas/haemoximetry analyser IVD, point-of-care
TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD
ADVIA Centaur® TSH3-UL (25-pack)
Siemens Healthcare Diagnostics Inc.
10361944
In Commercial Distribution

  • 00630414563268 ()
  • 00630414010564 ()
4862625

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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