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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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AmpliVue GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
Not in Commercial Distribution

  • 30014613312123 ()
M212

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Direct Strep Assay
QUIDEL CORPORATION
Direct Strep Assay
In Commercial Distribution

  • 30014613311126 ()
M112

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Strep A kit; 10 test kit
CEPHEID
XPRSTREPA-10
In Commercial Distribution

  • 07332940006372 ()
XPRSTREPA-10

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Strep A kit; 120 test kit
CEPHEID
XPRSTREPA-120
In Commercial Distribution

  • 07332940002503 ()
XPRSTREPA-120

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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; 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)
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