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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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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)
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)
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)
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)
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
For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Cyclosporine Extended Range Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444934
Not in Commercial Distribution

  • 00842768005268 ()
  • 00630414004198 ()
DF108

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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