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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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25-Strip; Strep A Throat Swab Test
WONDFO USA CO., LTD.
W39-S
In Commercial Distribution

  • 10816862021056 ()
  • 00816862021059 ()
  • 00816862028058 ()


  • 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
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
Strep A Rapid Test Strip (Throat Swab)
JANT PHARMACAL CORPORATION
ID513
In Commercial Distribution

  • 10763924513199 ()
  • 00763924513192 ()


  • 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
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
Rapid Response Strep A Test (Throat Swab) - for the qualitative detection of Streptococcus pyogenes (Strep A) antigens from throat swab specimens. For professional, prescription in vitro diagnostic use.
BTNX Inc
STA-15S25
In Commercial Distribution

  • 00722066006849 ()
  • 10722066006846 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
A qualitative immunoassay for the detection of Strep A Antigen from direct throat swab
Immunostics Company, Inc
IST-501-OBC33
In Commercial Distribution

  • 20722355001665 ()
  • 10722355001668 ()
  • 30722355001662 ()
  • 80722355001667 ()
IDSTREP-25

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Rapid Response Strep A Detection Strip (Throat Swab)
BTNX Inc
STR-15SGPU-25
In Commercial Distribution

  • 00722066010754 ()
  • 10722066010751 ()


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