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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 Class Implantable

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ImmunoCAP Specific IgE Calibrators 0-100 - 07333066019659

Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal-17.5, Cal-100) to form a complete calibration curve for the ImmunoCAP Specific IgE method.
Phadia AB
10-9460-01
In Commercial Distribution

  • 07333066019659 ()
10-9460-01

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

ImmunoCAP Specific IgE Curve Controls - 07333066019604

Contains three vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9408-01
In Commercial Distribution

  • 07333066019604 ()
10-9408-01

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

ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee - 07333066017549

ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
Phadia AB
14-6016-01
In Commercial Distribution

  • 07333066017549 ()
14-6016-01

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

ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee - 07333066017532

ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
Phadia AB
14-6015-01
In Commercial Distribution

  • 07333066017532 ()
14-6015-01

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

ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee - 07333066017525

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, - 07333066017518

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 - 07333066016924

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 - 07333066016917

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 - 07333066016009

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 - 07333066015903

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)
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