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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 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)

ImmunoCAP Specific IgE Conjugate 100 - 07333066019758

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 - 07333066019734

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 - 07333066019727

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)

ImmunoCAP Specific IgE 0-100 - 07333066019666

Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9462-02
In Commercial Distribution

  • 07333066019666 ()
10-9462-02

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