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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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RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Protein 1 Calibrator
Siemens Healthcare Diagnostics Inc.
11537520
In Commercial Distribution

  • 00630414313467 ()
  • 00630414636672 ()
11537520

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Test Strips for the Determination of Albumin and Creatinine in Urine
Siemens Healthcare Diagnostics Inc.
11643376
In Commercial Distribution

  • 00630414317434 ()
  • 00630414631707 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical
TSH3-ULII Atellica IM - RGT (REF) 2750T
Siemens Healthcare Diagnostics Inc.
11208704
In Commercial Distribution

  • 00630414624693 ()
11208704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM – RGT 550T
Siemens Healthcare Diagnostics Inc.
11208707
In Commercial Distribution

  • 00630414624525 ()
11208707

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - RGT 110T
Siemens Healthcare Diagnostics Inc.
11208706
In Commercial Distribution

  • 00630414624518 ()
11208706

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
Siemens Healthcare Diagnostics Inc.
11208703
In Commercial Distribution

  • 00630414624501 ()
11208703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT 500T
Siemens Healthcare Diagnostics Inc.
11208702
In Commercial Distribution

  • 00630414624488 ()
11208702

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry
The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
Siemens Healthcare Diagnostics Inc.
11537817
In Commercial Distribution

  • 00630414609515 ()
11537817

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