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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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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 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
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
BioStrep® A strip; 30 Test kit; CE; for LifeSign (Infolab)
PRINCETON BIOMEDITECH CORPORATION
BSP-185-30-06
In Commercial Distribution

  • 10743816000907 ()
BSP-185-30-06

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A strip; 12 Test sample kit
PRINCETON BIOMEDITECH CORPORATION
BSP-185-12-00
In Commercial Distribution

  • 10743816000884 ()
BSP-185-12-00

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A strip; 30 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-185-30-01
In Commercial Distribution

  • 10743816000877 ()
BSP-185-30-01

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