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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The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
10492730
In Commercial Distribution

  • 00630414589169 ()
10492730

  • Blood gas/haemoximetry analyser IVD, point-of-care
CMV IgG ADVIA Centaur - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10632820
In Commercial Distribution

  • 00630414588872 ()
10632820

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

  • Thyroglobulin antibody IVD, control
Vitamin D - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10630911
In Commercial Distribution

  • 00630414587882 ()
10630911

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator
TPO Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10630886
In Commercial Distribution

  • 00630414587837 ()
10630886

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control
Cocaine Metabolites - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378761
In Commercial Distribution

  • 00630414568775 ()
10378761

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Barbiturates - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378759
In Commercial Distribution

  • 00630414568751 ()
10378759

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
RAPIDPOINT® 340 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375808
In Commercial Distribution

  • 00630414568584 ()
10375808

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10376547
In Commercial Distribution

  • 00630414566771 ()
10376547

  • Calcium (Ca2+) electrode IVD
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