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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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No Description
Immundiagnostik AG
K 8870.US
In Commercial Distribution

  • 04050598010451 ()


  • Secretory immunoglobulin A (secretory IgA) IVD, kit, enzyme immunoassay (EIA)
No Description
Immundiagnostik AG
K 8870.20.US
In Commercial Distribution

  • 04050598007673 ()


  • Secretory immunoglobulin A (secretory IgA) IVD, kit, enzyme immunoassay (EIA)
Combo Veritor Reader 2 Hospital Flu Kit
BECTON, DICKINSON AND COMPANY
256070
Not in Commercial Distribution

  • 00382902560708 ()
256070

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
10 ea. Group A Strep (-) Control Swabs, 10 ea. Group A Strep (+) Control Swabs
BECTON, DICKINSON AND COMPANY
256049
In Commercial Distribution

  • 00382902560494 ()
256049

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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
One Step+ Strep A Dipstick 50 Test
HENRY SCHEIN, INC.
5700122
In Commercial Distribution

  • 20304040024168 ()
  • 10304040024161 ()
  • 00304040024164 ()
5700122

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
One Step+ Strep A Dipstick 25 Test
HENRY SCHEIN, INC.
1074050
In Commercial Distribution

  • 20304040024144 ()
  • 10304040024147 ()
  • 00304040024140 ()
1074050

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
One Step Pro Strep A Cassette
HENRY SCHEIN, INC.
9007570
In Commercial Distribution

  • 20304040053243 ()
  • 10304040053246 ()
  • 00304040053249 ()
9007570

  • 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
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