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 Class Implantable

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ImmunoCAP Allergen t208, Linden
Phadia AB
14-4823-01
In Commercial Distribution

  • 07333066004358 ()
14-4823-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g202, Maize, Corn
Phadia AB
14-4822-01
In Commercial Distribution

  • 07333066004341 ()
14-4822-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Phadia 2500E
Phadia AB
12-4100-01
In Commercial Distribution

  • 07333066020921 ()
12-4100-01

  • Fluorescent immunoassay analyser IVD, laboratory
Phadia 5000E
Phadia AB
12-4000-01
In Commercial Distribution

  • 07333066020907 ()
12-4000-01

  • Fluorescent immunoassay analyser IVD, laboratory
Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.
Phadia AB
83-1013-01
In Commercial Distribution

  • 07333066020075 ()
83-1013-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method.
Phadia AB
83-1000-01
In Commercial Distribution

  • 07333066020051 ()
83-1000-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA CCP Positive Control 2500/5000
Phadia AB
83-0008-81
In Commercial Distribution

  • 07333066014173 ()
  • 07333066020020 ()
83-0008-81

  • Plasma protein IVD, control
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 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 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)
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