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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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)
EliA IgA Conjugate 200
Phadia AB
83-0003-61
In Commercial Distribution

  • 07333066013794 ()
  • 07333066012865 ()
83-0003-61

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Curve Control Strip
Phadia AB
83-0003-41
In Commercial Distribution

  • 07333066013770 ()
  • 07333066012841 ()
83-0003-41

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Calibrator Strip
Phadia AB
83-0003-31
In Commercial Distribution

  • 07333066013763 ()
  • 07333066012834 ()
83-0003-31

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Calibrator Strip
Phadia AB
83-0002-91
In Commercial Distribution

  • 07333066013725 ()
  • 07333066012797 ()
83-0002-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Curve Control
Phadia AB
83-0002-71
In Commercial Distribution

  • 07333066013688 ()
  • 07333066012773 ()
83-0002-71

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgG Curve Control
Phadia AB
83-0000-91
In Commercial Distribution

  • 07333066013633 ()
  • 07333066012704 ()
83-0000-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
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