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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 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 m6, Alternaria alternata
Phadia AB
14-4106-01
In Commercial Distribution

  • 07333066001135 ()
14-4106-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen m2, Cladosporium herbarum
Phadia AB
14-4105-01
In Commercial Distribution

  • 07333066001128 ()
14-4105-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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 w6, Mugwort
Phadia AB
14-4103-01
In Commercial Distribution

  • 07333066001104 ()
14-4103-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t3, Common silver birch
Phadia AB
14-4102-01
In Commercial Distribution

  • 07333066001098 ()
14-4102-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g12, Cultivated rye
Phadia AB
14-4101-01
In Commercial Distribution

  • 07333066001081 ()
14-4101-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g6, Timothy
Phadia AB
14-4100-01
In Commercial Distribution

  • 07333066001074 ()
14-4100-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
Phadia AB
14-6014-01
In Commercial Distribution

  • 07333066017525 ()
14-6014-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine
Phadia AB
14-5997-02
In Commercial Distribution

  • 07333066017518 ()
14-5997-02

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e231, Allergen component rFel d 7 Cat
Phadia AB
14-6082-01
In Commercial Distribution

  • 07333066016924 ()
14-6082-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e230, Allergen component rCan f 6 Dog
Phadia AB
14-6081-01
In Commercial Distribution

  • 07333066016917 ()
14-6081-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut
Phadia AB
14-6041-01
In Commercial Distribution

  • 07333066016009 ()
14-6041-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w1, Common ragweed
Phadia AB
14-4531-01
In Commercial Distribution

  • 07333066015903 ()
14-4531-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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 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
Phadia AB
34-2275-51
In Commercial Distribution

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

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Conjugate 100
Phadia AB
34-2271-61
In Commercial Distribution

  • 07333066000183 ()
  • 07333066019758 ()
34-2271-61

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Curve Control Strip
Phadia AB
34-2271-21
In Commercial Distribution

  • 07333066000169 ()
  • 07333066019734 ()
34-2271-21

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Conjugate 400
Phadia AB
34-2271-02
In Commercial Distribution

  • 07333066000152 ()
  • 07333066019727 ()
34-2271-02

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