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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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IgG4 (M) - 00847627003003

No Description
BIOCARE MEDICAL LLC
ACI3115A
In Commercial Distribution

  • 00847627003003 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

IgG4 (M) - 00847627004208

No Description
BIOCARE MEDICAL LLC
API3115AA
In Commercial Distribution

  • 00847627004208 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Mumps Virus Antigen Substrate, 12 wells, For IFA Test System - B110MU80120

No Description
Bion Enterprises, Ltd.
MU-8012
In Commercial Distribution

  • B110MU80120 ()
MU-8012

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent

Mumps Virus Antigen Substrate, 6 wells, For IFA Test System - B110MU80060

No Description
Bion Enterprises, Ltd.
MU-8006
Not in Commercial Distribution

  • B110MU80060 ()
MU-8006

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent

Adenovirus Antigen Substrate, 12 wells, For IFA Test System - B110AD31120

No Description
Bion Enterprises, Ltd.
AD-3112
In Commercial Distribution

  • B110AD31120 ()
AD-3112

  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System - B110ME60120

No Description
Bion Enterprises, Ltd.
ME-6012
In Commercial Distribution

  • B110ME60120 ()
ME-6012

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent

Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System - B110ME60060

No Description
Bion Enterprises, Ltd.
ME-6006
Not in Commercial Distribution

  • B110ME60060 ()
ME-6006

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent

Henry Schein - 10304040130909

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)

Henry Schein - 10304040127879

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)

Schistosoma Antibody 96 Tests - 00813545026455

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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