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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® 500 System - 00630414589169

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 - 00630414589046

VERSANT® Lysis Buffer Kit
Siemens Healthcare Diagnostics Inc.
10634919
Not in Commercial Distribution

  • 00630414589046 ()
10634919

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur CMV IgG - 00630414588872

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) - 00630414588810

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) - 00630414588803

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) - 00630414588797

VERSANT® Tissue Preparation Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10632398
Not in Commercial Distribution

  • 00630414588797 ()
10632398

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® VitD Diluent Bottle - 00630414588773

Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10632114
In Commercial Distribution

  • 00630414588773 ()
10632114

  • Buffered sample diluent IVD

ADVIA Centaur® aTPO MCM - 00630414588476

TPO Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10630890
In Commercial Distribution

  • 00630414588476 ()
10630890

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

ADVIA Centaur® Systems QC anti-TPO 1,2 - 00630414587936

TPO Ab - CENTAUR - CONS - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630936
In Commercial Distribution

  • 00630414587936 ()
10630936

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

ADVIA Centaur® Systems Calibrator 0 - 00630414587912

TPO Ab - CENTAUR - CAL - 2 x2x1mL
Siemens Healthcare Diagnostics Inc.
10630932
In Commercial Distribution

  • 00630414587912 ()
10630932

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
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