FDA Registration
Active
🇸🇪 Sweden
Development Solution
Reg #: 9610566
·
FEI: 3002807876
·
Expires 2025
Products
1
Proprietary Names
307
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PHADIA AB
- Registration Number
- 9610566
- FEI Number
- 3002807876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- RAPSGATAN 7P
- City
- UPPSALA
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K051218
Owner / Operator
- Firm Name
- PHADIA AB
- Operator Number
- 9004441
- Address
- Rapsgatan 7P, P.O. Box 6460
- City
- UPPSALA
- State
- SE-C
- Postal Code
- 75137
- Country
- SE
US Agent
- Business Name
- Phadia US Inc.
- Contact Name
- Carla Krause
- Address
- 4169 Commercial Avenue
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
- [email protected]
- Phone
- 616 2864138
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2008-01-24 |
Proprietary Names
Development Solution
ImmunoCAP Allergen f45, Yeast
ImmunoCAP Allergen gx3, Grass pollen
ImmunoCAP Allergen f47, Garlic
ImmunoCAP Allergen g3, Cocksfoot
ImmunoCAP Allergen tx9, Tree pollen
ImmunoCAP Allergen g202, Maize, Corn
ImmunoCAP Allergen m6, Alternaria alternata
ImmunoCAP Allergen wx5, Weed pollen
ImmunoCAP Specific IgE 0-100
ImmunoCAP Allergen t5, American beech
ImmunoCAP Allergen g17, Bahia grass
ImmunoCAP Allergen m11, Rhizopus nigricans
ImmunoCAP Allergen tx6, Tree pollen
ImmunoCAP Allergen d70, Storage mite
ImmunoCAP Allergen k75, Isocyanate TDI
ImmunoCAP Allergen f207, Clam
ImmunoCAP Allergen fx15, Fruits
ImmunoCAP Allergen f87, Melon
ImmunoCAP Allergen f92, Banana
ImmunoCAP Allergen e84, Hamster epithelium
ImmunoCAP Allergen f201, Pecan nut
ImmunoCAP Allergen t1, Box-elder
ImmunoCAP Allergen tx1, Tree pollen
ImmunoCAP Allergen tx5, Tree pollen
ImmunoCAP Allergen f17, Hazel nut
ImmunoCAP Allergen t73, Australian pine
ImmunoCAP Allergen f10, Sesame seed
ImmunoCAP Allergen f5, Rye
ImmunoCAP Allergen e71, Mouse epithelium
ImmunoCAP Allergen w16, Rough marshelder
ImmunoCAP Allergen f41, Salmon
ImmunoCAP Allergen d1, House dust mite
ImmunoCAP Allergen e85, Chicken feathers
ImmunoCAP Allergen g13, Velvet grass
ImmunoCAP Allergen g16, Meadow foxtail
ImmunoCAP Allergen f256, Walnut
ImmunoCAP Allergen e5, Dog dander
Washing Solution
ImmunoCAP Allergen t11, Maple leaf sycamore, London plane
Phadia Information Data Manager Software Package
ImmunoCAP Allergen t10, Walnut
ImmunoCAP Allergen t6, Mountain juniper
ImmunoCAP Allergen m16, Curvularia lunata
ImmunoCAP Allergen f95, Peach
ImmunoCAP Allergen w2, Western ragweed
ImmunoCAP Allergen f232, Allergen component nGal d 2 Ovalbumin, Egg
ImmunoCAP Allergen f245, Egg
ImmunoCAP Allergen m1, Penicillium chrysogenum
ImmunoCAP Allergen w12, Goldenrod
ImmunoCAP Allergen t14, Cottonwood
ImmunoCAP Allergen t3, Common silver birch
ImmunoCAP Allergen f86, Parsley
ImmunoCAP Allergen g201, Barley
ImmunoCAP Allergen t15, White ash
ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.)
ImmunoCAP Allergen f89, Mustard
ImmunoCAP Allergen g6, Timothy
ImmunoCAP Allergen t19, Acacia
ImmunoCAP Allergen f84, Kiwi fruit
ImmunoCAP Allergen f8, Maize, Corn
ImmunoCAP Allergen g2, Bermuda grass
ImmunoCAP Allergen e88, Mouse epithelium, serum and urine proteins
ImmunoCAP Allergen g14, Cultivated oat
ImmunoCAP Allergen m10, Stemphylium herbarum
ImmunoCAP Allergen m81, Staphylococcal enterotoxin B
ImmunoCAP Allergen wx7, Weed pollen
ImmunoCAP Allergen fx2, Food
ImmunoCAP Allergen f25, Tomato
ImmunoCAP Allergen fx25, Food
ImmunoCAP Specific IgE Conjugate 100
ImmunoCAP Allergen f33, Orange
ImmunoCAP Allergen f203, Pistachio
ImmunoCAP Specific IgE Anti-IgE
ImmunoCAP Allergen f60, Jack mackerel, Scad
Dilution Well
ImmunoCAP Allergen i75, European hornet venom
ImmunoCAP Allergen f23, Crab
ImmunoCAP Allergen k84, Sunflower seed
ImmunoCAP Phadiatop
ImmunoCAP Allergen fx73, Meat
ImmunoCAP Allergen f12, Pea
ImmunoCAP Allergen f75, Egg yolk
ImmunoCAP Allergen i76, Berlin beetle
ImmunoCAP Allergen f40, Tuna
ImmunoCAP Allergen t8, Elm
ImmunoCAP Allergen f35, Potato
ImmunoCAP Allergen f215, Lettuce
ImmunoCAP Allergen c1, Penicilloyl G
ImmunoCAP Allergen t4, Hazel
ImmunoCAP Allergen f7, Oat
ImmunoCAP Allergen g12, Cultivated rye
ImmunoCAP Allergen g10, Johnson grass
ImmunoCAP Allergen g71, Canary grass
ImmunoCAP Allergen f235, Lentil
ImmunoCAP Allergen f2, Milk
ImmunoCAP Allergen d71, Storage mite
ImmunoCAP Allergen f58, Pacific squid
ImmunoCAP Allergen g15, Cultivated wheat
ImmunoCAP Allergen e81, Sheep epithelium
ImmunoCAP Allergen fx24, Food
Washing Solution Concentrate
ImmunoCAP Specific IgE Curve Controls
ImmunoCAP Allergen ex2, Animal proteins
ImmunoCAP Allergen w17, Firebush (Kochia)
ImmunoCAP Allergen f31, Carrot
ImmunoCAP Allergen i1, Honey bee venom
Phadia 5000
ImmunoCAP Allergen f213, Rabbit
ImmunoCAP Allergen ex1, Animal proteins
ImmunoCAP Allergen e201, Canary bird feathers
ImmunoCAP Allergen mx2, Moulds
ImmunoCAP Allergen tx7, Tree pollen
ImmunoCAP Allergen m4, Mucor racemosus
ImmunoCAP Allergen w15, Scale, Lenscale
ImmunoCAP Allergen e78, Budgerigar feathers
ImmunoCAP Allergen w18, Sheep sorrel
ImmunoCAP Allergen w13, Cocklebur
ImmunoCAP Allergen t20, Mesquite
ImmunoCAP Allergen c73, Insulin human
ImmunoCAP Allergen w20, Nettle
ImmunoCAP Allergen f91, Mango
ImmunoCAP Allergen f214, Spinach
ImmunoCAP Allergen w5, Wormwood
ImmunoCAP Allergen t9, Olive
ImmunoCAP Allergen f260, Broccoli
ImmunoCAP Allergen f15, White bean
ImmunoCAP Allergen f54, Sweet potato
ImmunoCAP Allergen t7, Oak
ImmunoCAP Allergen f202, Cashew nut
ImmunoCAP Allergen h2, House dust (Hollister-Stier Labs.)
ImmunoCAP Allergen g70, Wild rye grass
ImmunoCAP Allergen e83, Swine epithelium
ImmunoCAP Allergen t72, Queen palm
ImmunoCAP Allergen fx1, Food
ImmunoCAP Allergen e70, Goose feathers
ImmunoCAP Allergen k76, Isocyanate MDI
ImmunoCAP Allergen f255, Plum
ImmunoCAP Allergen f218, Paprika, Sweet pepper
ImmunoCAP Allergen i70, Fire ant
ImmunoCAP Allergen w8, Dandelion
ImmunoCAP Allergen t70, Mulberry
ImmunoCAP Allergen f204, Trout
ImmunoCAP Allergen t208, Linden
ImmunoCAP Allergen w11, Saltwort (prickly), Russian thistle
ImmunoCAP Allergen fx5, Food
ImmunoCAP Allergen m205, Trichophyton rubrum
ImmunoCAP Allergen i73, Blood worm
ImmunoCAP Allergen f259, Grape
ImmunoCAP Allergen k87, Allergen component nAsp o 21 Alpha-amylase, Aspergillus oryzae
ImmunoCAP Allergen k81, Ficus spp.
ImmunoCAP Allergen fx14, Vegetables
ImmunoCAP Allergen t18, Eucalyptus, Gum-tree
ImmunoCAP Allergen f216, Cabbage
ImmunoCAP Allergen w4, False ragweed
ImmunoCAP Allergen f37, Blue mussel
ImmunoCAP Allergen p1, Ascaris
ImmunoCAP Allergen f79, Gluten
ImmunoCAP Allergen f244, Cucumber
Phadia 1000
ImmunoCAP Allergen d74, House dust mite
ImmunoCAP Allergen m7, Botrytis cinerea
ImmunoCAP Allergen f36, Coconut
ImmunoCAP Allergen e86, Duck feathers
ImmunoCAP Allergen o1, Cotton, crude fibers
ImmunoCAP Allergen d2, House dust mite
ImmunoCAP Allergen gx2, Grass pollen
ImmunoCAP Allergen tx4, Tree pollen
ImmunoCAP Allergen f210, Pineapple
ImmunoCAP Allergen f1, Egg white
ImmunoCAP Allergen c5, Ampicilloyl
ImmunoCAP Allergen wx3, Weed pollen
ImmunoCAP Allergen fx13, Vegetables
ImmunoCAP Allergen e4, Cow dander
ImmunoCAP Allergen i71, Mosquito
ImmunoCAP Allergen g11, Brome grass
ImmunoCAP Allergen g9, Redtop, Bentgrass
ImmunoCAP Allergen mx1, Moulds
ImmunoCAP Allergen c2, Penicilloyl V
ImmunoCAP Allergen d3, House dust mite
ImmunoCAP Allergen gx1, Grass pollen
ImmunoCAP Allergen m3, Aspergillus fumigatus
ImmunoCAP Allergen e87, Rat epithelium, serum and urine proteins
ImmunoCAP Allergen f27, Beef
ImmunoCAP Allergen f50, Chub mackerel
ImmunoCAP Allergen f6, Barley
ImmunoCAP Allergen t12, Willow
ImmunoCAP Allergen f208, Lemon
ImmunoCAP Allergen ex70, Rodents
ImmunoCAP Allergen g1, Sweet vernal grass
ImmunoCAP Allergen wx1, Weed pollen
ImmunoCAP Allergen f3, Fish (cod)
ImmunoCAP Allergen m15, Trichoderma viride
ImmunoCAP Allergen f18, Brazil nut
ImmunoCAP Allergen fx7, Food
Washing Solution Additive
Phadia 250
ImmunoCAP Allergen f77, Allergen component nBos d 5 Beta-lactoglobulin, Milk
ImmunoCAP Allergen f94, Pear
ImmunoCAP Allergen t210, Privet
ImmunoCAP Allergen fx20, Food
ImmunoCAP Allergen f225, Pumpkin
ImmunoCAP Allergen f49, Apple
ImmunoCAP Allergen m8, Setomelanomma rostrata (Helminthosporium halodes)
ImmunoCAP Allergen w10, Goosefoot, Lamb's quarters
ImmunoCAP Allergen f61, Sardine, Pilchard
ImmunoCAP Allergen i5, Yellow hornet venom
ImmunoCAP Specific IgE Conjugate 400
ImmunoCAP Specific IgE Calibrator Strip 0-100
ImmunoCAP Specific IgE Negative Control
ImmunoCAP Allergen ex71, Feathers
ImmunoCAP Allergen f51, Bamboo shoot
ImmunoCAP Allergen k79, Phthalic anhydride
ImmunoCAP Allergen i8, Moth
ImmunoCAP Allergen f55, Common millet
ImmunoCAP Allergen f81, Cheese, cheddar type
ImmunoCAP Allergen f209, Grapefruit
ImmunoCAP Allergen c6, Amoxicilloyl
ImmunoCAP Allergen f284, Turkey meat
ImmunoCAP Allergen k78, Ethylene oxide
ImmunoCAP Allergen f82, Cheese, mold type
ImmunoCAP Allergen e1, Cat dander
ImmunoCAP Allergen m2, Cladosporium herbarum
ImmunoCAP Allergen m207, Aspergillus niger
ImmunoCAP Allergen t17, Japanese cedar
ImmunoCAP Allergen wx6, Weed pollen
ImmunoCAP Allergen d72, Storage mite
ImmunoCAP Allergen e3, Horse dander
ImmunoCAP Allergen f76, Allergen component nBos d 4 Alpha-lactalbumin, Milk
ImmunoCAP Allergen w7, Marguerite, Ox-eye daisy
ImmunoCAP Allergen f93, Cacao
Phadia 2500
ImmunoCAP Allergen f85, Celery
ImmunoCAP Allergen w6, Mugwort
ImmunoCAP Allergen f11, Buckwheat
ImmunoCAP Allergen e76, Mouse serum proteins
ImmunoCAP Allergen i2, White-faced hornet venom
ImmunoCAP Allergen gx4, Grass pollen
ImmunoCAP Allergen g4, Meadow fescue
ImmunoCAP Allergen f59, Octopus
ImmunoCAP Allergen t23, Italian/Mediterranean/Funeral cypress
ImmunoCAP Allergen f96, Avocado
ImmunoCAP Allergen tx8, Tree pollen
ImmunoCAP Allergen i6, Cockroach, German
ImmunoCAP Allergen f280, Black pepper
ImmunoCAP Allergen f9, Rice
ImmunoCAP Allergen f237, Apricot
ImmunoCAP Allergen f233, Allergen component nGal d 1 Ovomucoid, Egg
ImmunoCAP Allergen f78, Allergen component nBos d 8 Casein, Milk
ImmunoCAP Allergen f90, Malt
ImmunoCAP Allergen w9, Plantain (English), Ribwort
ImmunoCAP Allergen f44, Strawberry
ImmunoCAP Allergen f26, Pork
ImmunoCAP Allergen e74, Rat urine proteins
ImmunoCAP Allergen m202, Acremonium kiliense (Cephalosporium acremonium)
ImmunoCAP Allergen f48, Onion
ImmunoCAP Allergen e82, Rabbit epithelium
ImmunoCAP Allergen f13, Peanut
ImmunoCAP Allergen f24, Shrimp
ImmunoCAP Allergen k72, Ispaghula
ImmunoCAP Allergen t21, Melaleuca, Cajeput-tree
ImmunoCAP Allergen f80, Lobster
ImmunoCAP Allergen fx18, Food
ImmunoCAP Allergen f4, Wheat
ImmunoCAP Allergen f83, Chicken
ImmunoCAP Allergen f56, Foxtail millet
ImmunoCAP Allergen g7, Common reed
ImmunoCAP Allergen fx3, Food
ImmunoCAP Allergen m13, Phoma betae
ImmunoCAP Allergen m12, Aureobasidium pullulans
ImmunoCAP Allergen p4, Anisakis
ImmunoCAP Allergen m14, Epicoccum purpurascens
ImmunoCAP Allergen e6, Guinea pig epithelium
ImmunoCAP Allergen e75, Rat serum proteins
ImmunoCAP Allergen e77, Budgerigar droppings
ImmunoCAP Allergen e80, Goat epithelium
ImmunoCAP Allergen t16, White pine
Stop Solution
ImmunoCAP Allergen g5, Rye-grass
ImmunoCAP Allergen e73, Rat epithelium
ImmunoCAP Allergen hx2, House dust
ImmunoCAP Allergen e72, Mouse urine proteins
ImmunoCAP Allergen f254, Plaice
ImmunoCAP Allergen f299, Sweet chestnut
ImmunoCAP Allergen e89, Turkey feathers
ImmunoCAP Allergen k77, Isocyanate HDI
ImmunoCAP Allergen w21, Wall pellitory
ImmunoCAP Allergen m5, Candida albicans
ImmunoCAP Allergen d73, Storage mite
ImmunoCAP Allergen g8, Meadow grass, Kentucky blue
ImmunoCAP Allergen m9, Fusarium proliferatum
ImmunoCAP Allergen t2, Grey alder
ImmunoCAP Allergen c74, Gelatin bovine
ImmunoCAP Allergen wx2, Weed pollen
ImmunoCAP Allergen f242, Cherry
ImmunoCAP Allergen fx16, Fruits
ImmunoCAP Allergen f205, Herring
ImmunoCAP Allergen w3, Giant ragweed
ImmunoCAP Allergen t22, Pecan, Hickory
ImmunoCAP Allergen m80, Staphylococcal enterotoxin A
ImmunoCAP Allergen w14, Common pigweed
ImmunoCAP Allergen f290, Oyster
ImmunoCAP Specific IgE Curve Control Strip
ImmunoCAP Allergen f231, Milk boiled
ImmunoCAP Allergen w19, Wall pellitory
ImmunoCAP Allergen f14, Soybean
ImmunoCAP Allergen f88, Mutton
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device