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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 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
Microgenics Corporation
10016283
In Commercial Distribution

  • 00884883011861 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Microgenics Corporation
100147
In Commercial Distribution

  • 00884883001589 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
SEKISUI DIAGNOSTICS, LLC
148
In Commercial Distribution

  • 00742860100116 ()
  • 10742860100113 ()
148

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
141-10
In Commercial Distribution

  • 00742860100109 ()
  • 10742860100106 ()
141-10

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
755250
In Commercial Distribution

  • 00742860100024 ()
  • 10742860100021 ()
755250

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