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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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A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection
NANO-DITECH CORPORATION
MD8148
In Commercial Distribution

  • 10895160002684 ()
  • 00895160002687 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
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
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
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
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
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