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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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Sample Cups - ADVIA Chem. - CONS - 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10309450
In Commercial Distribution

  • 00630414482279 ()
  • 00630414003054 ()
073-0157-02

  • Assay container IVD, single-use
ADVIA® Chemistry Reagent Bottle 70 mL (Brown)
Siemens Healthcare Diagnostics Inc.
10309449
In Commercial Distribution

  • 00630414482262 ()
073-0152-02

  • Multiple clinical chemistry analyser IVD, laboratory
RAPIDPoint® 400/405/500 Wash/Waste Cartridge, for in vitro diagnostics use with the RAPIDPoint® 400/405/500 series systems.
Siemens Healthcare Diagnostics Inc.
10329097
In Commercial Distribution

  • 00630414482163 ()
  • 00630414009612 ()
129672

  • Wash/cleaning solution IVD, automated/semi-automated system
HAV Total - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10322682
In Commercial Distribution

  • 00630414481883 ()
5500077

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10322676
In Commercial Distribution

  • 00630414481876 ()
5498862

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alcohol / Ammonia Kit - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10309217
In Commercial Distribution

  • 00630414479286 ()
  • 00630414003047 ()
6549444

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10315660
In Commercial Distribution

  • 00630414479095 ()
5085

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
ISE Reference Electrode - ADVIA Chem. - CONS - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309465
In Commercial Distribution

  • 00630414478654 ()
073-0653-01

  • Reference electrode IVD
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