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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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EliA IgA Calibrators - 07333066020075

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)

EliA IgG Calibrators - 07333066020051

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)

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)

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 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)
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