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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 f98, Gliadin - 07333066010991

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 f433, Allergen component rTri a 14 LTP, Wheat - 07333066010922

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 m229, Allergen component rAlt a 1, Alternaria alternata - 07333066010540

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 - 07333066010533

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 - 07333066010519

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 - 07333066010496

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 - 07333066010489

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 - 07333066010465

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 - 07333066010441

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 - 07333066010427

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 - 07333066010397

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 - 07333066010151

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 - 07333066010090

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 - 07333066009933

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 - 07333066009902

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 - 07333066009889

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 - 07333066009865

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 Rare Allergen Rm226, Staphylococcal enterotoxin TSST - 07333066009841

ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST
Phadia AB
14-5301-10
In Commercial Distribution

  • 07333066009841 ()
14-5301-10

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

ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus - 07333066009780

ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus
Phadia AB
14-5296-10
In Commercial Distribution

  • 07333066009780 ()
14-5296-10

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

ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus - 07333066009766

ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus
Phadia AB
14-5295-10
In Commercial Distribution

  • 07333066009766 ()
14-5295-10

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

ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profilin, Timothy - 07333066009698

ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profilin, Timothy
Phadia AB
14-5292-01
In Commercial Distribution

  • 07333066009698 ()
14-5292-01

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

ImmunoCAP Allergen g210, Allergen component rPhl p 7 Timothy - 07333066009650

ImmunoCAP Allergen g210, Allergen component rPhl p 7 Timothy
Phadia AB
14-5290-01
In Commercial Distribution

  • 07333066009650 ()
14-5290-01

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

ImmunoCAP Allergen g209, Allergen component rPhl p 6 Timothy - 07333066009636

ImmunoCAP Allergen g209, Allergen component rPhl p 6 Timothy
Phadia AB
14-5289-01
In Commercial Distribution

  • 07333066009636 ()
14-5289-01

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

ImmunoCAP Allergen t220, Allergen component rBet v 4 Birch - 07333066009599

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 Rare Allergen Rf347, Quinoa - 07333066009544

ImmunoCAP Rare Allergen Rf347, Quinoa
Phadia AB
14-5284-10
In Commercial Distribution

  • 07333066009544 ()
14-5284-10

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

ImmunoCAP Allergen Rf346, Abalone - 07333066009520

ImmunoCAP Allergen Rf346, Abalone
Phadia AB
14-5283-10
In Commercial Distribution

  • 07333066009520 ()
14-5283-10

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

ImmunoCAP Allergen Rf345, Macadamia nut - 07333066009506

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)

ImmunoCAP Rare Allergen Rf344, Sage - 07333066009483

ImmunoCAP Rare Allergen Rf344, Sage
Phadia AB
14-5281-10
In Commercial Distribution

  • 07333066009483 ()
14-5281-10

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

ImmunoCAP Allergen Rf343, Raspberry - 07333066009469

ImmunoCAP Allergen Rf343, Raspberry
Phadia AB
14-5280-10
In Commercial Distribution

  • 07333066009469 ()
14-5280-10

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

ImmunoCAP Allergen Rf342, Olive - 07333066009445

ImmunoCAP Allergen Rf342, Olive
Phadia AB
14-5279-10
In Commercial Distribution

  • 07333066009445 ()
14-5279-10

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

ImmunoCAP Allergen Rf306, Lime - 07333066008035

ImmunoCAP Allergen Rf306, Lime
Phadia AB
14-5188-10
In Commercial Distribution

  • 07333066008035 ()
14-5188-10

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

ImmunoCAP Allergen t212, Cedar - 07333066007984

ImmunoCAP Allergen t212, Cedar
Phadia AB
14-5185-01
In Commercial Distribution

  • 07333066007984 ()
14-5185-01

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

ImmunoCAP Allergen Rtx10, Tree pollen - 07333066007953

ImmunoCAP Allergen Rtx10, Tree pollen
Phadia AB
14-5183-10
In Commercial Distribution

  • 07333066007953 ()
14-5183-10

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

ImmunoCAP Allergen Rfx17, Fruits - 07333066007915

ImmunoCAP Allergen Rfx17, Fruits
Phadia AB
14-5179-10
In Commercial Distribution

  • 07333066007915 ()
14-5179-10

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

ImmunoCAP Rare Allergen Rt217, Peppertree - 07333066007854

ImmunoCAP Rare Allergen Rt217, Peppertree
Phadia AB
14-5167-10
In Commercial Distribution

  • 07333066007854 ()
14-5167-10

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

ImmunoCAP Rare Allergen Rf301, Persimon (kaki fruit, sharon) - 07333066007816

ImmunoCAP Rare Allergen Rf301, Persimon (kaki fruit, sharon)
Phadia AB
14-5161-10
In Commercial Distribution

  • 07333066007816 ()
14-5161-10

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

ImmunoCAP Allergen Rf302, Mandarin (tangerine, clementine, satsumas) - 07333066007793

ImmunoCAP Allergen Rf302, Mandarin (tangerine, clementine, satsumas)
Phadia AB
14-5160-10
In Commercial Distribution

  • 07333066007793 ()
14-5160-10

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

ImmunoCAP Allergen Rt206, Chestnut - 07333066007519

ImmunoCAP Allergen Rt206, Chestnut
Phadia AB
14-5140-10
In Commercial Distribution

  • 07333066007519 ()
14-5140-10

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

ImmunoCAP Allergen Rf297, Gum arabic - 07333066007472

ImmunoCAP Allergen Rf297, Gum arabic
Phadia AB
14-5138-10
In Commercial Distribution

  • 07333066007472 ()
14-5138-10

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

ImmunoCAP Allergen Ro201, Tobacco leaf - 07333066007434

ImmunoCAP Allergen Ro201, Tobacco leaf
Phadia AB
14-5136-10
In Commercial Distribution

  • 07333066007434 ()
14-5136-10

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