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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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BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit
BECTON, DICKINSON AND COMPANY
256040
In Commercial Distribution

  • 00382902560401 ()
  • 50382902560406 ()
256040

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A Flip
MCKESSON MEDICAL-SURGICAL INC.
181-34125
In Commercial Distribution

  • 00612479242869 ()
  • 00612479244122 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
TEST, KIT STREP A DIPSTICK WAI
MCKESSON MEDICAL-SURGICAL INC.
5003
In Commercial Distribution

  • 00612479240100 ()
  • 00612479202733 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
TEST, KIT STREP A DIPSTICK WAI
MCKESSON MEDICAL-SURGICAL INC.
4999
In Commercial Distribution

  • 00612479240094 ()
  • 00612479202726 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Uni-Gold™ C. difficile Toxin A/B, 20 Tests
MARDX DIAGNOSTICS, INC.
1206630
In Commercial Distribution

  • 05391516748773 ()
1206630

  • Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid
Alere Signify™ Strep A Dipstick
ALERE SAN DIEGO, INC.
01P46-50
In Commercial Distribution

  • 10815845020055 ()
  • 00815845020058 ()
4584925047

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Alere Acceava™ Strep A
ALERE SAN DIEGO, INC.
92001
In Commercial Distribution

  • 10815845020031 ()
  • 00815845020034 ()
4580295008

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens.
Alere Scarborough, Inc.
730-025
In Commercial Distribution

  • 10811877010453 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Clearview™ Strep A Exact II Dipstick
ALERE SAN DIEGO, INC.
92002
In Commercial Distribution

  • 10815845020024 ()
  • 00815845020027 ()
4581225020

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens.
Alere Scarborough, Inc.
735-025
In Commercial Distribution

  • 10811877010927 ()


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