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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 f27, Beef - 07333066002064

ImmunoCAP Allergen f27, Beef
Phadia AB
14-4209-01
In Commercial Distribution

  • 07333066002064 ()
14-4209-01

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

ImmunoCAP Allergen fx3, Food - 07333066002057

ImmunoCAP Allergen fx3, Food
Phadia AB
14-4208-01
In Commercial Distribution

  • 07333066002057 ()
14-4208-01

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

ImmunoCAP Allergen fx2, Food - 07333066002040

ImmunoCAP Allergen fx2, Food
Phadia AB
14-4207-01
In Commercial Distribution

  • 07333066002040 ()
14-4207-01

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

ImmunoCAP Allergen fx1, Food - 07333066002033

ImmunoCAP Allergen fx1, Food
Phadia AB
14-4206-01
In Commercial Distribution

  • 07333066002033 ()
14-4206-01

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

ImmunoCAP Allergen mx1, Moulds - 07333066002019

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 tx5, Tree pollen - 07333066001982

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 g7, Common reed - 07333066001869

ImmunoCAP Allergen g7, Common reed
Phadia AB
14-4187-01
In Commercial Distribution

  • 07333066001869 ()
14-4187-01

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

ImmunoCAP Allergen f83, Chicken - 07333066001845

ImmunoCAP Allergen f83, Chicken
Phadia AB
14-4185-01
In Commercial Distribution

  • 07333066001845 ()
14-4185-01

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

ImmunoCAP Allergen m2, Cladosporium herbarum - 07333066001128

ImmunoCAP Allergen m2, Cladosporium herbarum
Phadia AB
14-4105-01
In Commercial Distribution

  • 07333066001128 ()
14-4105-01

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

ImmunoCAP Allergen w6, Mugwort - 07333066001104

ImmunoCAP Allergen w6, Mugwort
Phadia AB
14-4103-01
In Commercial Distribution

  • 07333066001104 ()
14-4103-01

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

ImmunoCAP Allergen t3, Common silver birch - 07333066001098

ImmunoCAP Allergen t3, Common silver birch
Phadia AB
14-4102-01
In Commercial Distribution

  • 07333066001098 ()
14-4102-01

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

ImmunoCAP Allergen g12, Cultivated rye - 07333066001081

ImmunoCAP Allergen g12, Cultivated rye
Phadia AB
14-4101-01
In Commercial Distribution

  • 07333066001081 ()
14-4101-01

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

ImmunoCAP Allergen g6, Timothy - 07333066001074

ImmunoCAP Allergen g6, Timothy
Phadia AB
14-4100-01
In Commercial Distribution

  • 07333066001074 ()
14-4100-01

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

ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed - 07333066021706

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 Specific IgE Calibrator Strip 0-100 - 07333066019802

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 100 - 07333066019758

ImmunoCAP Specific IgE Conjugate 100
Phadia AB
34-2271-61
In Commercial Distribution

  • 07333066000183 ()
  • 07333066019758 ()
34-2271-61

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

ImmunoCAP Specific IgE Curve Control Strip - 07333066019734

ImmunoCAP Specific IgE Curve Control Strip
Phadia AB
34-2271-21
In Commercial Distribution

  • 07333066000169 ()
  • 07333066019734 ()
34-2271-21

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

ImmunoCAP Specific IgE Conjugate 400 - 07333066019727

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 Specific IgE 0-100 - 07333066019666

Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9462-02
In Commercial Distribution

  • 07333066019666 ()
10-9462-02

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

ImmunoCAP Specific IgE Calibrators 0-100 - 07333066019659

Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal-17.5, Cal-100) to form a complete calibration curve for the ImmunoCAP Specific IgE method.
Phadia AB
10-9460-01
In Commercial Distribution

  • 07333066019659 ()
10-9460-01

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

ImmunoCAP Specific IgE Curve Controls - 07333066019604

Contains three vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9408-01
In Commercial Distribution

  • 07333066019604 ()
10-9408-01

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

ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee - 07333066017549

ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
Phadia AB
14-6016-01
In Commercial Distribution

  • 07333066017549 ()
14-6016-01

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

ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee - 07333066017532

ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
Phadia AB
14-6015-01
In Commercial Distribution

  • 07333066017532 ()
14-6015-01

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

ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee - 07333066017525

ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
Phadia AB
14-6014-01
In Commercial Distribution

  • 07333066017525 ()
14-6014-01

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

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, - 07333066017518

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine
Phadia AB
14-5997-02
In Commercial Distribution

  • 07333066017518 ()
14-5997-02

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

ImmunoCAP Allergen e231, Allergen component rFel d 7 Cat - 07333066016924

ImmunoCAP Allergen e231, Allergen component rFel d 7 Cat
Phadia AB
14-6082-01
In Commercial Distribution

  • 07333066016924 ()
14-6082-01

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

ImmunoCAP Allergen e230, Allergen component rCan f 6 Dog - 07333066016917

ImmunoCAP Allergen e230, Allergen component rCan f 6 Dog
Phadia AB
14-6081-01
In Commercial Distribution

  • 07333066016917 ()
14-6081-01

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

ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut - 07333066016009

ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut
Phadia AB
14-6041-01
In Commercial Distribution

  • 07333066016009 ()
14-6041-01

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

ImmunoCAP Allergen w1, Common ragweed - 07333066015903

ImmunoCAP Allergen w1, Common ragweed
Phadia AB
14-4531-01
In Commercial Distribution

  • 07333066015903 ()
14-4531-01

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

ImmunoCAP Allergen d202, Allergen component rDer p 1, House dust mite - 07333066011073

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 f441, Allergen component rJug r 1, Walnut - 07333066011042

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 f440, Allergen component nCor a 9, Hazelnut - 07333066011028

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 f439, Allergen component rCor a 14, Hazelnut - 07333066011004

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 t224, Allergen Component rOle e 1, Olive - 07333066010960

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 - 07333066010939

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 e227, Allergen component rEqu c 1, Horse - 07333066010915

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 Ri207, Cockroach, Oriental - 07333066009421

ImmunoCAP Allergen Ri207, Cockroach, Oriental
Phadia AB
14-5275-10
In Commercial Distribution

  • 07333066009421 ()
14-5275-10

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

ImmunoCAP Allergen Ri206, Cockroach, American - 07333066009407

ImmunoCAP Allergen Ri206, Cockroach, American
Phadia AB
14-5274-10
In Commercial Distribution

  • 07333066009407 ()
14-5274-10

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

ImmunoCAP Allergen Ri205, Bumble bee - 07333066009384

ImmunoCAP Allergen Ri205, Bumble bee
Phadia AB
14-5270-10
In Commercial Distribution

  • 07333066009384 ()
14-5270-10

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

ImmunoCAP Allergen Rf341, Cranberry - 07333066009360

ImmunoCAP Allergen Rf341, Cranberry
Phadia AB
14-5269-10
In Commercial Distribution

  • 07333066009360 ()
14-5269-10

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

ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red) - 07333066009353

ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red)
Phadia AB
14-5268-10
In Commercial Distribution

  • 07333066009353 ()
14-5268-10

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

ImmunoCAP Rare Allergen Rf339, Allspice - 07333066009339

ImmunoCAP Rare Allergen Rf339, Allspice
Phadia AB
14-5267-10
In Commercial Distribution

  • 07333066009339 ()
14-5267-10

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

ImmunoCAP Allergen c202, Suxamethonium (Succinylcholine) - 07333066009315

ImmunoCAP Allergen c202, Suxamethonium (Succinylcholine)
Phadia AB
14-5266-10
In Commercial Distribution

  • 07333066009315 ()
14-5266-10

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

ImmunoCAP Allergen Rf337, Sole - 07333066009230

ImmunoCAP Allergen Rf337, Sole
Phadia AB
14-5256-10
In Commercial Distribution

  • 07333066009230 ()
14-5256-10

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

ImmunoCAP Allergen f335, Lupine seed - 07333066009193

ImmunoCAP Allergen f335, Lupine seed
Phadia AB
14-5254-10
In Commercial Distribution

  • 07333066009193 ()
14-5254-10

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

ImmunoCAP Allergen Rt218, Virginia live oak - 07333066009155

ImmunoCAP Allergen Rt218, Virginia live oak
Phadia AB
14-5252-10
In Commercial Distribution

  • 07333066009155 ()
14-5252-10

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

ImmunoCAP Rare Allergen Rf333, Linseed - 07333066009117

ImmunoCAP Rare Allergen Rf333, Linseed
Phadia AB
14-5250-10
In Commercial Distribution

  • 07333066009117 ()
14-5250-10

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

ImmunoCAP Rare Allergen Rf332, Mint - 07333066009094

ImmunoCAP Rare Allergen Rf332, Mint
Phadia AB
14-5249-10
In Commercial Distribution

  • 07333066009094 ()
14-5249-10

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

ImmunoCAP Allergen Rf329, Watermelon - 07333066009018

ImmunoCAP Allergen Rf329, Watermelon
Phadia AB
14-5245-10
In Commercial Distribution

  • 07333066009018 ()
14-5245-10

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

ImmunoCAP Allergen Rf328, Fig - 07333066008998

ImmunoCAP Allergen Rf328, Fig
Phadia AB
14-5244-10
In Commercial Distribution

  • 07333066008998 ()
14-5244-10

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