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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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OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010006

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

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

NOVEOS Fluo Beads - 00816879028881

No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


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

NOVEOS Substrate Pack - 00816879028850

No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


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

NOVEOS Conjugate IgE - 00816879028836

No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


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

NOVEOS Diluent A Kit - 00816879028829

No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


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

ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee - 07333066015071

ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee
Phadia AB
14-6004-01
In Commercial Distribution

  • 07333066015071 ()
14-6004-01

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

ImmunoCAP Allergen f442, Allergen component rJug r 3 LTP, Walnut - 07333066011059

ImmunoCAP Allergen f442, Allergen component rJug r 3 LTP, Walnut
Phadia AB
14-5954-01
In Commercial Distribution

  • 07333066011059 ()
14-5954-01

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

ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew nut - 07333066011035

ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew nut
Phadia AB
14-5760-01
In Commercial Distribution

  • 07333066011035 ()
14-5760-01

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

ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog - 07333066011011

ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog
Phadia AB
14-5755-01
In Commercial Distribution

  • 07333066011011 ()
14-5755-01

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

ImmunoCAP Allergen f98, Gliadin - 07333066010991

ImmunoCAP Allergen f98, Gliadin
Phadia AB
14-5752-01
In Commercial Distribution

  • 07333066010991 ()
14-5752-01

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