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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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ADVIA® Chemistry FRT Ferritin Reagents - 00630414590189

Ferritin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution

  • 00630414590189 ()
4862277

  • Ferritin IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry B2M ß2-Microglobulin Reagents - 00630414590165

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

RAPIDPoint® 500 Measurement Cartridge - 00630414589770

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 - 00630414589763

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 - 00630414589756

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 - 00630414589749

ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution

  • 00630414589749 ()
10696880

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

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

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
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