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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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PRO ADVANTAGE A 25/BX
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080033
In Commercial Distribution

  • M220P0800335 ()
  • M220P0800333 ()
P080033

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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
Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.
Phadia AB
83-1013-01
In Commercial Distribution

  • 07333066020075 ()
83-1013-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgA method.
Phadia AB
10-9308-01
In Commercial Distribution

  • 07333066019574 ()
10-9308-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
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