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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 Size Device Size Type Device Class Implantable

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ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy
Phadia AB
14-4990-01
In Commercial Distribution

  • 07333066005768 ()
14-4990-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i208, Allergen component rApi m 1 Phospholipase A2, Honey bee
Phadia AB
14-4987-01
In Commercial Distribution

  • 07333066005744 ()
14-4987-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen d205, Allergen component rDer p 10 Tropomyosin, House dust mite
Phadia AB
14-4985-01
In Commercial Distribution

  • 07333066005737 ()
14-4985-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort
Phadia AB
14-4983-01
In Commercial Distribution

  • 07333066005713 ()
14-4983-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f428, Allergen component rCor a 1 PR-10 Hazel nut
Phadia AB
14-4981-01
In Commercial Distribution

  • 07333066005706 ()
14-4981-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f427, Allergen component rAra h 9 LTP, Peanut
Phadia AB
14-4980-01
In Commercial Distribution

  • 07333066005690 ()
14-4980-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass
Phadia AB
14-4972-01
In Commercial Distribution

  • 07333066005638 ()
14-4972-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w231, Allergen component nArt v 1 Mugwort
Phadia AB
14-4970-01
In Commercial Distribution

  • 07333066005614 ()
14-4970-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w230, Allergen component nAmb a 1 Ragweed
Phadia AB
14-4969-01
In Commercial Distribution

  • 07333066005591 ()
14-4969-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f425, Allergen component rCor a 8, Hazel nut
Phadia AB
14-4968-01
In Commercial Distribution

  • 07333066005584 ()
14-4968-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen d203, Allergen component rDer p 2, House dust mite
Phadia AB
14-4967-01
In Commercial Distribution

  • 07333066005577 ()
14-4967-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen d202, Allergen component nDer p 1, House dust mite
Phadia AB
14-4966-01
In Commercial Distribution

  • 07333066005560 ()
14-4966-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f424, Allergen component rAra h 3 Peanut
Phadia AB
14-4965-01
In Commercial Distribution

  • 07333066005553 ()
14-4965-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f423, Allergen component rAra h 2 Peanut
Phadia AB
14-4964-01
In Commercial Distribution

  • 07333066005546 ()
14-4964-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut
Phadia AB
14-4963-01
In Commercial Distribution

  • 07333066005539 ()
14-4963-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f421, Allergen component rPru p 4 Profilin, Peach
Phadia AB
14-4962-01
In Commercial Distribution

  • 07333066005522 ()
14-4962-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f420, Allergen component rPru p 3 LTP, Peach
Phadia AB
14-4961-01
In Commercial Distribution

  • 07333066005515 ()
14-4961-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach
Phadia AB
14-4960-01
In Commercial Distribution

  • 07333066005508 ()
14-4960-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e102, Allergen component rCan f 2 Dog
Phadia AB
14-4956-01
In Commercial Distribution

  • 07333066005478 ()
14-4956-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e101, Allergen component rCan f 1 Dog
Phadia AB
14-4955-01
In Commercial Distribution

  • 07333066005461 ()
14-4955-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat
Phadia AB
14-4954-01
In Commercial Distribution

  • 07333066005454 ()
14-4954-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rw82, Careless weed
Phadia AB
14-4953-10
In Commercial Distribution

  • 07333066005447 ()
14-4953-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rw46, Dog fennel
Phadia AB
14-4952-10
In Commercial Distribution

  • 07333066005423 ()
14-4952-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rw45, Alfalfa
Phadia AB
14-4951-10
In Commercial Distribution

  • 07333066005409 ()
14-4951-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rw23, Yellow dock
Phadia AB
14-4950-10
In Commercial Distribution

  • 07333066005386 ()
14-4950-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt71, Red mulberry
Phadia AB
14-4949-10
In Commercial Distribution

  • 07333066005362 ()
14-4949-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt57, Red cedar
Phadia AB
14-4948-10
In Commercial Distribution

  • 07333066005348 ()
14-4948-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt56, Bayberry
Phadia AB
14-4947-10
In Commercial Distribution

  • 07333066005324 ()
14-4947-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt55, Scotch broom
Phadia AB
14-4946-10
In Commercial Distribution

  • 07333066005300 ()
14-4946-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt54, Russian olive
Phadia AB
14-4945-10
In Commercial Distribution

  • 07333066005287 ()
14-4945-10

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