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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

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® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

VERSANT® Sample Preparation 1.2 Reagents (Box 2) - 00630414587141

VERSANT® Sample Preparation 1.2 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10629801
Not in Commercial Distribution

  • 00630414587141 ()
10629801

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Sample Preparation 1.2 Reagents (Box 1) - 00630414587134

VERSANT® Sample Preparation 1.2 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10629800
Not in Commercial Distribution

  • 00630414587134 ()
10629800

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® XP Analyzer - 00630414585475

ADVIA® CENTAUR® XP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10471899
In Commercial Distribution

  • 00630414585475 ()
078-A011R03

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® Testosterone 2 MCM - 00630414580654

Testosterone 2 Master Curve Material SET - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492623
In Commercial Distribution

  • 00630414580654 ()
10492623

  • Total testosterone IVD, control
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