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
Phone
616 2864138

Products

Device Name Product Code
System, Test, Radioallergosorbent (Rast) Immunological DHB

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