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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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ImmunoCAP Allergen t1, Box-elder - 07333066001609

ImmunoCAP Allergen t1, Box-elder
Phadia AB
14-4161-01
In Commercial Distribution

  • 07333066001609 ()
14-4161-01

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

ImmunoCAP Allergen m1, Penicillium chrysogenum - 07333066001593

ImmunoCAP Allergen m1, Penicillium chrysogenum
Phadia AB
14-4160-01
In Commercial Distribution

  • 07333066001593 ()
14-4160-01

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

ImmunoCAP Allergen f3, Fish (cod) - 07333066001586

ImmunoCAP Allergen f3, Fish (cod)
Phadia AB
14-4159-01
In Commercial Distribution

  • 07333066001586 ()
14-4159-01

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

ImmunoCAP Allergen w10, Goosefoot, Lamb's quarters - 07333066001579

ImmunoCAP Allergen w10, Goosefoot, Lamb's quarters
Phadia AB
14-4157-01
In Commercial Distribution

  • 07333066001579 ()
14-4157-01

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

ImmunoCAP Allergen w9, Plantain (English), Ribwort - 07333066001562

ImmunoCAP Allergen w9, Plantain (English), Ribwort
Phadia AB
14-4156-01
In Commercial Distribution

  • 07333066001562 ()
14-4156-01

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

ImmunoCAP Allergen e5, Dog dander - 07333066001173

ImmunoCAP Allergen e5, Dog dander
Phadia AB
14-4110-01
In Commercial Distribution

  • 07333066001173 ()
14-4110-01

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

ImmunoCAP Allergen d1, House dust mite - 07333066001142

ImmunoCAP Allergen d1, House dust mite
Phadia AB
14-4107-01
In Commercial Distribution

  • 07333066001142 ()
14-4107-01

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

ImmunoCAP Allergen w21, Wall pellitory - 07333066001111

ImmunoCAP Allergen w21, Wall pellitory
Phadia AB
14-4104-01
In Commercial Distribution

  • 07333066001111 ()
14-4104-01

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

ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed - 07333066021706

ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Phadia AB
14-6109-01
In Commercial Distribution

  • 07333066021706 ()
14-6109-01

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

ImmunoCAP Specific IgE Calibrator Strip 0-100 - 07333066019802

ImmunoCAP Specific IgE Calibrator Strip 0-100
Phadia AB
34-2275-51
In Commercial Distribution

  • 07333066000527 ()
  • 07333066019802 ()
34-2275-51

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