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 o214, Allergen component MUXF3 CCD, Bromelain
Phadia AB
14-5339-01
In Commercial Distribution

  • 07333066010465 ()
14-5339-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f351, Allergen component rPen a 1 Tropomyosin, Shrimp
Phadia AB
14-5335-01
In Commercial Distribution

  • 07333066010397 ()
14-5335-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Ro212, Streptavidin
Phadia AB
14-5320-10
In Commercial Distribution

  • 07333066010151 ()
14-5320-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Antigen RGe92, Parrot serum proteins, feathers and droppings
Phadia AB
14-5317-10
In Commercial Distribution

  • 07333066010090 ()
14-5317-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t222, Arizona cypress
Phadia AB
14-5309-01
In Commercial Distribution

  • 07333066009933 ()
14-5309-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Antigen RGm24, Stachybotrys atra
Phadia AB
14-5304-10
In Commercial Distribution

  • 07333066009902 ()
14-5304-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Antigen RGm23, Thermoactinomyces vulgaris
Phadia AB
14-5303-10
In Commercial Distribution

  • 07333066009889 ()
14-5303-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Antigen RGm22, Micropolyspora faeni
Phadia AB
14-5302-10
In Commercial Distribution

  • 07333066009865 ()
14-5302-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t220, Allergen component rBet v 4 Birch
Phadia AB
14-5287-01
In Commercial Distribution

  • 07333066009599 ()
14-5287-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf345, Macadamia nut
Phadia AB
14-5282-10
In Commercial Distribution

  • 07333066009506 ()
14-5282-10

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