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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Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Testosterone II (TSTII) - ADVIA Centaur® - RGT (REF) – 500T
Siemens Healthcare Diagnostics Inc.
10696864
In Commercial Distribution

  • 00630414591155 ()
10696864

  • Total testosterone IVD, kit, chemiluminescent immunoassay
RAPIDPoint® 500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491447
In Commercial Distribution

  • 00630414589756 ()
10491447

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution

  • 00630414589749 ()
10696880

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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
VERSANT® Lysis Buffer Kit
Siemens Healthcare Diagnostics Inc.
10634919
Not in Commercial Distribution

  • 00630414589046 ()
10634919

  • Nucleic acid extraction/isolation kit IVD
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
VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Tissue Preparation Reagents, (Box 2)
Siemens Healthcare Diagnostics Inc.
10632399
Not in Commercial Distribution

  • 00630414588803 ()
10632399

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Tissue Preparation Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10632398
Not in Commercial Distribution

  • 00630414588797 ()
10632398

  • Nucleic acid extraction/isolation kit IVD
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