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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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Meta G UCLA Abutment-Meta G UCLA Abutment - 08800016106794

No Description
Cowellmedi Co.,Ltd
SGH452N
In Commercial Distribution

  • 08800016106794 ()


  • Dental implant suprastructure, permanent, preformed

McKesson - 00612479261501

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)

McKesson - 00612479261471

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 - 10743816001591

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 - 10743816001584

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 - 10743816001164

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 - 10743816001157

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 - 10743816001140

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 - 10743816001133

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)

cobas® Strep A Quality Control Kit for use on the cobas® Liat® System - 00875197005646

No Description
Roche Molecular Systems, Inc.
07402678190
In Commercial Distribution

  • 00875197005646 ()
07402678190

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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