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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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QkVue Strep A Dpstk, 4T Samp
QUIDEL CORPORATION
20163
In Commercial Distribution

  • 30014613331452 ()
20163

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Sofia Strep A 25T
QUIDEL CORPORATION
20231
In Commercial Distribution

  • 30014613202318 ()
20231

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
QkVue Strep A Dpstk 10T
QUIDEL CORPORATION
20152
In Commercial Distribution

  • 30014613201526 ()
20152

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
QkVue Strep A Dpstk 25T
QUIDEL CORPORATION
20125
In Commercial Distribution

  • 30014613201250 ()
20125

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
QkVue+ Strep A, 25T
QUIDEL CORPORATION
20122
In Commercial Distribution

  • 30014613201229 ()
20122

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
QkVue Strep A Dpstk 50T
QUIDEL CORPORATION
20108
In Commercial Distribution

  • 30014613201083 ()
20108

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
QkVue InLine Strep A 25T
QUIDEL CORPORATION
00343
In Commercial Distribution

  • 30014613003434 ()
00343

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369151 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369144 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
141
In Commercial Distribution

  • 00742860001413 ()
  • 10742860001410 ()
141

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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