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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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
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
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
Phadia AB
14-5136-10
In Commercial Distribution

  • 07333066007434 ()
14-5136-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf227, Sugar-beet seed
Phadia AB
14-5102-10
In Commercial Distribution

  • 07333066007090 ()
14-5102-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Rare Allergen f226, Pumpkin seed
Phadia AB
14-5098-10
In Commercial Distribution

  • 07333066007052 ()
14-5098-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f253, Pine nut, pignoles
Phadia AB
14-5093-10
In Commercial Distribution

  • 07333066007014 ()
14-5093-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Rare Allergen Rf267, Cardamon
Phadia AB
14-5058-10
In Commercial Distribution

  • 07333066006550 ()
14-5058-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Rare Allergen Rf217, Brussel sprouts
Phadia AB
14-5054-10
In Commercial Distribution

  • 07333066006499 ()
14-5054-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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 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 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 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 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 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 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 Rf369, Catfish
Phadia AB
14-4930-10
In Commercial Distribution

  • 07333066005010 ()
14-4930-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf147, Gulf flounder
Phadia AB
14-4928-10
In Commercial Distribution

  • 07333066004976 ()
14-4928-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen fx18, Food
Phadia AB
14-4852-01
In Commercial Distribution

  • 07333066004648 ()
14-4852-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen fx15, Fruits
Phadia AB
14-4850-01
In Commercial Distribution

  • 07333066004624 ()
14-4850-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen fx13, Vegetables
Phadia AB
14-4848-01
In Commercial Distribution

  • 07333066004600 ()
14-4848-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i4, Paper wasp venom
Phadia AB
14-4526-01
In Commercial Distribution

  • 07333066004143 ()
14-4526-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i3, Common wasp venom (Yellow jacket)
Phadia AB
14-4525-01
In Commercial Distribution

  • 07333066004136 ()
14-4525-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f78, Allergen component nBos d 8 Casein, Milk
Phadia AB
14-4524-01
In Commercial Distribution

  • 07333066004129 ()
14-4524-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f77, Allergen component nBos d 5 Beta-lactoglobulin, Milk
Phadia AB
14-4523-01
In Commercial Distribution

  • 07333066004112 ()
14-4523-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f76, Allergen component nBos d 4 Alpha-lactalbumin, Milk
Phadia AB
14-4522-01
In Commercial Distribution

  • 07333066004105 ()
14-4522-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f256, Walnut
Phadia AB
14-4521-01
In Commercial Distribution

  • 07333066004099 ()
14-4521-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
ImmunoCAP Allergen ex2, Animal proteins
Phadia AB
14-4512-01
In Commercial Distribution

  • 07333066004068 ()
14-4512-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen k82, Latex
Phadia AB
14-4511-01
In Commercial Distribution

  • 07333066004051 ()
14-4511-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen m205, Trichophyton rubrum
Phadia AB
14-4483-01
In Commercial Distribution

  • 07333066003979 ()
14-4483-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen o1, Cotton, crude fibers
Phadia AB
14-4476-01
In Commercial Distribution

  • 07333066003962 ()
14-4476-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen p4, Anisakis
Phadia AB
14-4475-01
In Commercial Distribution

  • 07333066003955 ()
14-4475-01

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