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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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Toxoplasma gondii , control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB60490 ()
BSB 6049

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control
Toxoplasma gondii Control Slides
BIO SB, INC.
BSB-9416-CS
In Commercial Distribution

  • B502BSB9416CS0 ()
BSB-9416-CS

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Bion Enterprises, Ltd.
MU-8006
Not in Commercial Distribution

  • B110MU80060 ()
MU-8006

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
ME-6006
Not in Commercial Distribution

  • B110ME60060 ()
ME-6006

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
AD-3112
In Commercial Distribution

  • B110AD31120 ()
AD-3112

  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
MU-8012
In Commercial Distribution

  • B110MU80120 ()
MU-8012

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
ME-6012
In Commercial Distribution

  • B110ME60120 ()
ME-6012

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent
Splash Shields for Ear Wash system Ridged Tube
HENRY SCHEIN, INC.
5701917
In Commercial Distribution

  • 00304040130902 ()
  • 10304040130909 ()
5701917

  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Ear Washer - Rigid Tube, 3 Tips, IFU
HENRY SCHEIN, INC.
5701885
In Commercial Distribution

  • 00304040127872 ()
  • 10304040127879 ()
5701885

  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
SCHISTO-96
In Commercial Distribution

  • 00813545026455 ()
SCHISTO-96

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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