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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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No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
No Description
DIASORIN MOLECULAR LLC
MOL2850
In Commercial Distribution

  • 20816101025569 ()
MOL2850

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
TEST KIT, H PYLORI (25/KT)
MCKESSON MEDICAL-SURGICAL INC.
181-37025
In Commercial Distribution

  • 00612479261518 ()
  • 00612479261501 ()
  • 00612479261495 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
TEST KIT, H PYLORI (10/KT)
MCKESSON MEDICAL-SURGICAL INC.
181-37010
In Commercial Distribution

  • 00612479261488 ()
  • 00612479261471 ()
  • 00612479261464 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-25-02
In Commercial Distribution

  • 10743816001591 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card; 10 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-10-02
In Commercial Distribution

  • 10743816001584 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card; 30 Test kit- CE (Procedure Card)
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-30-07
In Commercial Distribution

  • 10743816001164 ()
BSP-406WB-30-07

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 30 Test kit (Procedure Card)
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-30-05
In Commercial Distribution

  • 10743816001157 ()
BSP-406WB-30-05

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-10-01
In Commercial Distribution

  • 10743816001140 ()
BSP-406WB-10-01

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-35-01
In Commercial Distribution

  • 10743816001133 ()
BSP-406WB-35-01

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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