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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Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
Rinse additive for CLINITEK Novus® automated urine chemistry system.
Siemens Healthcare Diagnostics Inc.
10697754
In Commercial Distribution

  • 00630414590936 ()
  • 00630414010007 ()
10697754

  • Buffered wash solution IVD
Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests
Siemens Healthcare Diagnostics Inc.
10697575
In Commercial Distribution

  • 00630414590394 ()
  • 00630414005966 ()
10697575

  • Triglyceride IVD, kit, spectrophotometry
ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control
Ferritin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution

  • 00630414590189 ()
4862277

  • Ferritin IVD, kit, nephelometry/turbidimetry
b2 Microglobulin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361937
Not in Commercial Distribution

  • 00630414590165 ()
4862161

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361936
Not in Commercial Distribution

  • 00630414590158 ()
4862129

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
RAPIDPoint® 500 Measurement Cartridge (750 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.
10491449
In Commercial Distribution

  • 00630414589770 ()
10491449

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (400 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.
10491448
In Commercial Distribution

  • 00630414589763 ()
10491448

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
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
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
In Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Tissue Preparation Reagents, (Box 2)
Siemens Healthcare Diagnostics Inc.
10632399
In Commercial Distribution

  • 00630414588803 ()
10632399

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Tissue Preparation Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10632398
In Commercial Distribution

  • 00630414588797 ()
10632398

  • Nucleic acid extraction/isolation kit IVD
Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10632114
In Commercial Distribution

  • 00630414588773 ()
10632114

  • Buffered sample diluent IVD
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
TPO Ab - CENTAUR - CONS - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630936
In Commercial Distribution

  • 00630414587936 ()
10630936

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
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
TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

  • Thyroglobulin antibody IVD, control
EATG - CENTAUR - CAL 1 - 2 pack
Siemens Healthcare Diagnostics Inc.
10630915
In Commercial Distribution

  • 00630414587899 ()
10630915

  • Thyroglobulin antibody IVD, calibrator
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 - 500 tests
Siemens Healthcare Diagnostics Inc.
10630887
In Commercial Distribution

  • 00630414587844 ()
  • 00630414005911 ()
10630887

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
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 - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator
PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control
CMV IgG ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10630613
In Commercial Distribution

  • 00630414587448 ()
  • 00630414224138 ()
10630613

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
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
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