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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
Cowellmedi Co.,Ltd
SGH453N
In Commercial Distribution

  • 08800016106855 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGN452N
In Commercial Distribution

  • 08800016106800 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH452N
In Commercial Distribution

  • 08800016106794 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Lonza Walkersville, Inc.
15-1004J
In Commercial Distribution

  • 00840075403159 ()
15-1004J

  • Ex vivo cell culture medium
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; 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)
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)
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; 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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