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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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A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs
GERMAINE LABORATORIES, INC
75525
In Commercial Distribution

  • 00695684755201 ()
  • 00695684755256 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.
GERMAINE LABORATORIES, INC
73040
In Commercial Distribution

  • 00695684730406 ()
  • 00695684730401 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.
GERMAINE LABORATORIES, INC
73025
In Commercial Distribution

  • 00695684730253 ()
  • 00695684730215 ()


  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens.
BTNX Inc
STR-15S25
In Commercial Distribution

  • 00722066000014 ()
  • 00722066004234 ()
STR-15S25

  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H. pylori A
In Commercial Distribution

  • 00850487007654 ()


  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H. pylori A
In Commercial Distribution

  • 00850487007647 ()


  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A H5N1 Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
H5N1POS
In Commercial Distribution

  • 00850051429653 ()
H5N1POS

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control
Disposable Gloves,Nitrile,M,PK100
GRAINGER INTERNATIONAL, INC.
2VLY3V
In Commercial Distribution

  • 20194484320458 ()
  • 10194484320451 ()
  • 00194484320454 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
ASLO - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318208
In Commercial Distribution

  • 00630414517681 ()
3055483

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
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