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 Total IgE Anti-IgE
Phadia AB
14-4509-01
In Commercial Distribution

  • 07333066004037 ()
14-4509-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Conjugate 400
Phadia AB
34-2325-42
In Commercial Distribution

  • 07333066000664 ()
  • 07333066019864 ()
34-2325-42

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Calibrator Strip
Phadia AB
34-2274-81
In Commercial Distribution

  • 07333066000367 ()
  • 07333066019796 ()
34-2274-81

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Curve Control Strip
Phadia AB
34-2274-51
In Commercial Distribution

  • 07333066000220 ()
  • 07333066019789 ()
34-2274-51

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Conjugate 100
Phadia AB
34-2272-22
In Commercial Distribution

  • 07333066000206 ()
  • 07333066019772 ()
34-2272-22

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9517-02
In Commercial Distribution

  • 07333066019673 ()
10-9517-02

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9257-01
In Commercial Distribution

  • 07333066019529 ()
10-9257-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method.
Phadia AB
10-9252-01
In Commercial Distribution

  • 07333066019512 ()
10-9252-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Phadia 5000E+E
Phadia AB
12-4000-02
In Commercial Distribution

  • 07333066020914 ()
12-4000-02

  • Fluorescent immunoassay analyser IVD, laboratory
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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