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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ImmunoCAP Allergen hx2, House dust
Phadia AB
14-4205-01
In Commercial Distribution

  • 07333066002026 ()
14-4205-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen mx1, Moulds
Phadia AB
14-4204-01
In Commercial Distribution

  • 07333066002019 ()
14-4204-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen ex1, Animal proteins
Phadia AB
14-4203-01
In Commercial Distribution

  • 07333066002002 ()
14-4203-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen tx6, Tree pollen
Phadia AB
14-4202-01
In Commercial Distribution

  • 07333066001999 ()
14-4202-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen tx5, Tree pollen
Phadia AB
14-4201-01
In Commercial Distribution

  • 07333066001982 ()
14-4201-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen tx4, Tree pollen
Phadia AB
14-4200-01
In Commercial Distribution

  • 07333066001975 ()
14-4200-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen tx1, Tree pollen
Phadia AB
14-4199-01
In Commercial Distribution

  • 07333066001968 ()
14-4199-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen wx6, Weed pollen
Phadia AB
14-4198-01
In Commercial Distribution

  • 07333066001951 ()
14-4198-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen wx5, Weed pollen
Phadia AB
14-4197-01
In Commercial Distribution

  • 07333066001944 ()
14-4197-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen wx3, Weed pollen
Phadia AB
14-4196-01
In Commercial Distribution

  • 07333066001937 ()
14-4196-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen wx1, Weed pollen
Phadia AB
14-4195-01
In Commercial Distribution

  • 07333066001920 ()
14-4195-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen gx4, Grass pollen
Phadia AB
14-4194-01
In Commercial Distribution

  • 07333066001913 ()
14-4194-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen gx3, Grass pollen
Phadia AB
14-4193-01
In Commercial Distribution

  • 07333066001906 ()
14-4193-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Phadia AB
14-6109-01
In Commercial Distribution

  • 07333066021706 ()
14-6109-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen d202, Allergen component rDer p 1, House dust mite
Phadia AB
14-5996-01
In Commercial Distribution

  • 07333066011073 ()
14-5996-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f442, Allergen component rJug r 3 LTP, Walnut
Phadia AB
14-5954-01
In Commercial Distribution

  • 07333066011059 ()
14-5954-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f441, Allergen component rJug r 1, Walnut
Phadia AB
14-5762-01
In Commercial Distribution

  • 07333066011042 ()
14-5762-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew nut
Phadia AB
14-5760-01
In Commercial Distribution

  • 07333066011035 ()
14-5760-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f440, Allergen component nCor a 9, Hazelnut
Phadia AB
14-5758-01
In Commercial Distribution

  • 07333066011028 ()
14-5758-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog
Phadia AB
14-5755-01
In Commercial Distribution

  • 07333066011011 ()
14-5755-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f439, Allergen component rCor a 14, Hazelnut
Phadia AB
14-5754-01
In Commercial Distribution

  • 07333066011004 ()
14-5754-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f98, Gliadin
Phadia AB
14-5752-01
In Commercial Distribution

  • 07333066010991 ()
14-5752-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t224, Allergen Component rOle e 1, Olive
Phadia AB
14-5705-01
In Commercial Distribution

  • 07333066010960 ()
14-5705-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e228, Allergen component rFel d 4, Cat
Phadia AB
14-5702-01
In Commercial Distribution

  • 07333066010939 ()
14-5702-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat
Phadia AB
14-5701-01
In Commercial Distribution

  • 07333066010922 ()
14-5701-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e227, Allergen component rEqu c 1, Horse
Phadia AB
14-5700-01
In Commercial Distribution

  • 07333066010915 ()
14-5700-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen m229, Allergen component rAlt a 1, Alternaria alternata
Phadia AB
14-5346-01
In Commercial Distribution

  • 07333066010540 ()
14-5346-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t225, Allergen component rBet v 6 Birch
Phadia AB
14-5345-01
In Commercial Distribution

  • 07333066010533 ()
14-5345-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f354, Allergen component rBer e 1, Brazil nut
Phadia AB
14-5343-01
In Commercial Distribution

  • 07333066010519 ()
14-5343-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut
Phadia AB
14-5341-01
In Commercial Distribution

  • 07333066010496 ()
14-5341-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f353, Allergen component rGly m 4 PR-10, Soy
Phadia AB
14-5340-01
In Commercial Distribution

  • 07333066010489 ()
14-5340-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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 g215, Allergen component rPhl p 5b Timothy
Phadia AB
14-5338-01
In Commercial Distribution

  • 07333066010441 ()
14-5338-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen c7, Cefaclor
Phadia AB
14-5336-10
In Commercial Distribution

  • 07333066010427 ()
14-5336-10

  • 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)
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