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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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HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
KIT, OPTIGEN US Environmental 36 (100ND)
Minaris Medical America, Inc.
85268
In Commercial Distribution

  • 00813382012185 ()
85268

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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