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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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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)
CATH PACK, STRL F G
Cardinal Health 200, LLC
SAN68CAT15
In Commercial Distribution

  • 50195594392527 ()
  • 10195594392529 ()
SAN68CAT15

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
LINING CEMENT 15 g liquid
Gc America Inc.
000108
In Commercial Distribution

  • 24548161329375 ()
  • 14548161329378 ()

  • Total Volume: 12 Milliliter
000108

  • Glass ionomer dental cement
LINING CEMENT 15 g powder
Gc America Inc.
000107
In Commercial Distribution

  • 24548161329368 ()
  • 14548161329361 ()

  • Weight: 15 Gram
000107

  • Glass ionomer dental cement
CATH PACK, STRL F G
Cardinal Health 200, LLC
SAN68CAT13
In Commercial Distribution

  • 50195594091017 ()
  • 10195594091019 ()
SAN68CAT13

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
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