FDA Registration Active 🇺🇸 United States

PHADIA US INC.

Reg #: 3004973408 · FEI: 3004973408 · Expires 2026
Products
52
Proprietary Names
668
Establishment Types
1
Classifications
52

Registration Details

Registration Name
PHADIA US INC.
Registration Number
3004973408
FEI Number
3004973408
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
4169 COMMERCIAL AVE.
City
Portage
State
MI
ZIP
49002
Country
US

Regulatory Submissions

510(k) Number
K894623

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

Products

Device Name Product Code
Respiratory Syncytial Virus, Antigen, Antibody, Ifa LKT
Extractable Antinuclear Antibody, Antigen And Control LLL
Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
Antigen, Cf, (Including Cf Control), Varicella-Zoster GQW
Antibody Igm, If, Epstein-Barr Virus LJN
System, Test, Radioallergosorbent (Rast) Immunological DHB
Multi-Analyte Controls, All Kinds (Assayed) JJY
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
Antibodies, Gliadin MST
Anti-Dna Antibody, Antigen And Control LSW
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
General Purpose Reagent PPM
Container, Specimen, Non-Sterile NNI
Mounting Media LEB
Antisera, Cf, Herpesvirus Hominis 1,2 GQO
Anti-Sm Antibody, Antigen And Control LKP
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Antiserum, Hai, Rubeola GRG
Anti-Rnp Antibody, Antigen And Control LKO
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody NYO
Tryptase Assay System OYL
Antiserum, Fluorescent, Mumps Virus GRA
System, Test, Thyroid Autoantibody JZO
Calculator/Data Processing Module, For Clinical Use JQP
Antiserum, Fluorescent, Epstein-Barr Virus JRY
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Ige, Antigen, Antiserum, Control DGC
Anti-Ribosomal P Antibodies MQA
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
System, Test, Anticardiolipin Immunological MID
Antisera, Fluorescent, Chlamydia Spp. LKI
Dna-Reagents, Mycoplasma Spp. LQG
Antinuclear Antibody, Antigen, Control LKJ
Multi-Analyte Controls Unassayed OHQ
Agent, Clearing KEM
System, Test, Rheumatoid Factor DHR
Reagents, Specific, Analyte MVU
Antigen, Cf (Including Cf Control), Cytomegalovirus GQH
Reagent, Borrelia Serological Reagent LSR
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX
Antiserum, Fluorescent, Rubeola GRE
Ph Buffer JCC
Antisera, Hai, Influenza Virus A, B, C GNS
Antisera, Fluorescent, Adenovirus 1-33 GNY
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens PUW
Station, Pipetting And Diluting, For Clinical Use JQW
Quality Control Slides LJG

Proprietary Names

BION Respiratory Syncytial Virus IFA; Substrate Slide EliA SymphonyS Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E ELIA CELIKEY IGG WELL BION Varicella-Zoster IFA; Substrate Slides BION EBV IgM (VCA) Test System ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut EliA dsDNA Positive Control 250 EliA ANA 3 Positive Control 250 EliA dsDNA Positive Control 2500/5000 EliA ANA Positive Control 2500/5000 EliA ANA 3 Positive Control 2500/5000 EliA M2 Positive Control 2500/5000 EliA Celiac Positive Control 2500/5000 EliA APS Positive Control 2500/5000 EliA RF Positive Control 2500/5000 EliA ANCA/GBM Positive Control 2500/5000 EliA™ M2 Immunoassay EliA™ M2 Positive Control 250 EliA Gliadin DP IgA Well EliA Gliadin DP IgG Well AESKUSLIDES® nDNA (Crithidia luciliae) nDNA positive control IFA negative control IgG Conjugate ANA Conjugate IgM Conjugate IgG Removal Reagent Diluent BION IFA EliA Stool Extraction Kit plus BION IFA MOUNTING MEDIA EliA Celiac Positive Control 250 BION Herpes Simplex Type 1; Antibody Test System BION Herpes Simplex Type 2 EliA SmDP-S Phadia 2500+ LAS Connector ImmunoCAP Dummy ImmunoCAP EliA MPOs Immunoassay EliA PR3s Immunoassay EliA GBM Immunoassay ImmunoCAP Allergen d202, Allergen component rDer p 1, House dust mite Phadia Maintenance Solution Large Phadia Maintenance Solution Small BION MEASLES-M IFA TEST SYSTEM ImmunoCAP Allergen f338 EliA Jo-1 EliA RNP70 Phadia 250 and Phadia 2500, Phadia 5000 Instrument E series EliA RNA Pol III ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew nut ImmunoCAP Allergen f441, Allergen component rJug r1, Walnut ImmunoCAP Allergen f442, Allergen component rJug r 3, LTP, Walnut ImmunoCAP Allergen f440, Allergen component nCor a 9, Hazelnut ImmunoCAP Allergen f439, Allergen component rCor a 14, Hazelnut ImmunoCAP Tryptase Curve Control Strip ImmunoCAP Tryptase Conjugate 50 ImmunoCAP Tryptase Calibrator Strip BION Mumps Virus IFA; Substrate Slides ImmunoCAP Tryptase Anti-Tryptase ImmunoCAP Tryptase Control EliA IgG/IgM/IgA Negative Control 2500/5000 EliA Thyroid Positive Control 2500/5000 EliA anti-TPO Immunoassay EliA anti-TG Immunoassay EliA Thyroid Positive Control 250 HERA (HER-1000) ImmunoCAP Allergen e102, Allergen Component rCan f 2, Dog ImmunoCAP Allergen e101, Allergen Component rCan f 1, Dog ImmunoCAP Allergen t224, Allergen component rOle e 1, Olive ImmunoCAP Allergen f353, Allergen component rGly m 4 PR-10, Soy ImmunoCAP Allergen e221, Allergen component nCan f 3, Dog serum albumin ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy ImmunoCAP Allergen t240, Allergen component rOle e 9, Olive ImmunoCAP Allergen t227, Allergen component nOle e 7 LTP, Olive ImmunoCAP Allergen e226, Allergen component rCan f 5, Dog ImmunoCAP Allergen f432, Allergen component nGly m 6 Glycinin, Soy BION EBV IgG (VCA) Test System ImmunoCAP Allergen, k82 Latex ImmunoCAP Specific IgE Control H ImmunoCAP Specific IgE Control L ImmunoCAP Specific IgE Control M ImmunoCAP Allergen d201, House dust mite BION Antinuclear Antibody (ANA), Test System ImmunoCAP Allergen i4, Paper wasp venom ImmunoCAP Allergen i3, common wasp venom (Yellow Jacket) ImmunoCAP Allergen f309, Chick Pea ImmunoCAP Allergen f236, Cow's Milk Whey ImmunoCAP Allergen t222, Cupressus arizonica ImmunoCAP Allergen t212, Cedar ImmunoCAP Total IgE Conjugate 400 ImmunoCAP Total IgE Conjugate 100 ImmunoCAP Total IgE Anti-IgE ImmunoCAP Total IgE Calibrator Strip ImmunoCAP Total IgE Control LMH ImmunoCAP Total IgE Curve Control Strip ImmunoCAP Total IgE ImmunoCAP IgE/ ECP/ Tryptase Sample Diluent EliA Rib-P EliA™ Scl-70S Immunoassay ImmunoCAP Allergen f416, Allergen Component rTri a 19 Omega-5 Gliadin, Wheat ImmunoCAP Allergen f449, Allergen Component rSes i 1, Sesame seed ImmunoCAP Allergen f433, Allergen Component rTri a 14 LTP, Wheat ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut ImmunoCAP Allergen f427, Allergen component rAra h 9 LTP, Peanut ImmunoCAP Allergen m229, Allergen component rAlt a 1, Alternaria alternata ImmunoCAP Allergen d203, Allergen component rDer p 2, House dust mite ImmunoCAP Allergen w230, Allergen component nAmb a 1 Ragweed ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut ImmunoCAP Allergen f424, Allergen component rAra h 3 Peanut ImmunoCAP Allergen d205, Allergen component rDer p 10 Tropomyosin, House dust mite ImmunoCAP Allergen f423, Allergen component rAra h 2 Peanut ImmunoCAP Allergen e220, Allergen component rFel d 2 Cat serum albumin ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass ImmunoCAP Allergen e94, Allergen component rFel d 1 Cat AESKUSLIDES® ANCA EliA B2-Glycoprotein I IgM EliA B2-Glycoprotein I IgG EliA Cardiolipin IgG EliA APS Positive Control 250 EliA Cardiolipin IgM EliA IgM Curve Control Strips EliA IgM Conjugate 200 EliA IgM Calibrator Well EliA IgG/IgM/IgA Negative Control 250 EliA IgM Conjugate 50 EliA IgM Calibrator Strips BION Chlamydia IFA; Substrate Slides BION MYCOPLASMA PNEUMONIA EliA La EliA Ro EliA CENP EliA U1RNP Quality Club EliA Autoimmunity Quality Club Total IgE Quality Club Specific IgE AESQC® Pool 1; AESQC® Pool 2; AESQC® Pool 3; AESQC® Pool 4; AESQC® Pool 5; AESQC® Pool Mix AESQC® ANA HEp-2 Nucleolar; AESQC® ANA HEp-2 Panel 1; AESQC® ANA HEp-2 Speckled; AESQC® IFA Negative Control AESQC® ANA HEp-2 Centromere; AESQC® ANA HEp-2 Cytoplasmic; AESQC® ANA HEp-2 Homogeneous EliA Stool Extraction Buffer plus EliA ANA Positive Control 250 EliA dsDNA Well EliA RF Positive Control 250 EliA RF IgA Well EliA RF IgM Well EliA RF IgM Immunoassay ImmunoCAP Allergen Rt55, Scotch broom ImmunoCAP Allergen Rw203, Rape ImmunoCAP Rare Allergen Rf286, Mare's milk ImmunoCAP Rare Allergen Rm201, Tilletia tritici (Ustilago tritici) ImmunoCAP Allergen Rf337, Sole ImmunoCAP Allergen Rf345, Macadamia nut ImmunoCAP Allergen Rm208, Chaetomium globosum ImmunoCAP Allergen Rf313, Anchovy ImmunoCAP Allergen Rt209, Horn beam ImmunoCAP Rare Allergen Rw207, Lupin ImmunoCAP Allergen Rf289, Date ImmunoCAP Allergen Rf308, Sardine (Pilchard) ImmunoCAP Allergen Rf314, Snail ImmunoCAP Allergen Rfx22, Nuts ImmunoCAP Allergen Rf346, Abalone ImmunoCAP Allergen Rm211, Trichophyton ment. var interdigitale ImmunoCAP Allergen Rf288, Blueberry ImmunoCAP Rare Allergen Rf217, Brussel sprouts ImmunoCAP Allergen Rt205, Elder ImmunoCAP Allergen Rm209, Penicillium glabrum ImmunoCAP Allergen Rf271, Anise ImmunoCAP Rare Allergen Rt211, Sweet gum ImmunoCAP Allergen Rf263, Green pepper (unripe seed) ImmunoCAP Rare Allergen Re217, Ferret epithelium ImmunoCAP Allergen Rf268, Clove ImmunoCAP Allergen Rt37, Bald cypress ImmunoCAP Allergen f335, Lupine seed ImmunoCAP Allergen Rtx10, Tree pollen ImmunoCAP Allergen Rf274, Marjoram ImmunoCAP Allergen Rf206, Mackerel ImmunoCAP Allergen Rrx3, Regional ImmunoCAP Allergen Rf283, Oregano ImmunoCAP Rare Allergen Rm204, Ulocladium chartarum ImmunoCAP Rare Allergen Re206, Rabbit serum proteins ImmunoCAP Allergen Re218, Chicken droppings ImmunoCAP Allergen Rt201, Spruce ImmunoCAP Allergen Rf320, Crayfish ImmunoCAP Allergen Rfx17, Fruits ImmunoCAP Allergen Rt45, Cedar elm ImmunoCAP Allergen Rf291, Cauliflower ImmunoCAP Allergen Rt218, Virginia live oak ImmunoCAP Allergen Rf304, Langust (spiny lobster) ImmunoCAP Allergen Rf42, Haddock ImmunoCAP Allergen Rf343, Raspberry ImmunoCAP Allergen Rt41, White hickory ImmunoCAP Rare Allergen Rf246, Guar, guar gum ImmunoCAP Allergen Ri205, Bumble bee ImmunoCAP Allergen Rk208, Allergen component nGal d 4 Lysozyme, Egg ImmunoCAP Allergen f224, Poppy seed ImmunoCAP Allergen Rf261, Asparagus ImmunoCAP Allergen Rf312, Swordfish ImmunoCAP Rare Allergen Rf319, Beetroot ImmunoCAP Allergen Rf269, Basil ImmunoCAP Allergen Rf282, Nutmeg ImmunoCAP Allergen Rf258, Squid ImmunoCAP Allergen Rf317, Coriander ImmunoCAP Rare Allergen Re219, Chicken serum proteins ImmunoCAP Allergen Rf220, Cinnamon ImmunoCAP Allergen Rt206, Chestnut ImmunoCAP Allergen Ri206, Cockroach, American ImmunoCAP Allergen Rt44, Hackberry ImmunoCAP Allergen Rf414, Tilapia ImmunoCAP Allergen Rf342, Olive ImmunoCAP Allergen Ri204, Horse fly ImmunoCAP Allergen Rf413, Pollock ImmunoCAP Rare Allergen Rf347, Quinoa ImmunoCAP Allergen Rf341, Cranberry ImmunoCAP Allergen Rf369, Catfish ImmunoCAP Allergen Rf227, Sugar-beet seed ImmunoCAP Allergen Rf273, Thyme ImmunoCAP Allergen Rf278, Bay leaf ImmunoCAP Ro212, Streptavidin ImmunoCAP Allergen Rf381, Red snapper ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus ImmunoCAP Allergen Rf221, Coffee ImmunoCAP Allergen Rf297, Gum arabic ImmunoCAP Rare Allergen Rf301, Persimon (kaki fruit, sharon) ImmunoCAP Allergen Rt57, Red cedar ImmunoCAP Allergen Rf300, Goat milk ImmunoCAP Allergen Rf302, Mandarin (tangerine, clementine, satsumas) ImmunoCAP Rare Allergen Re211, Rabbit, urine proteins ImmunoCAP Allergen Rf262, Aubergine, eggplant ImmunoCAP Rare Allergen Rf333, Linseed ImmunoCAP Allergen Re204, Allergen component nBos d 6 BSA, Cow ImmunoCAP Rare Allergen Rf332, Mint ImmunoCAP Allergen Rt71, Red mulberry ImmunoCAP Rare Allergen Rf296, Carob ImmunoCAP Rare Allergen Rt217, Peppertree ImmunoCAP Allergen Rf415, Walleye pike ImmunoCAP Allergen Rf182, Lima bean ImmunoCAP Rare Allergen f266, Mace ImmunoCAP Allergen Re215, Pigeon feathers ImmunoCAP Allergen Rt213, Pine ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus ImmunoCAP Allergen c202, Suxamethonium (Succinylcholine) ImmunoCAP Allergen Rf265, Caraway ImmunoCAP Allergen w22, Japanese Hop ImmunoCAP Allergen Rf306, Lime ImmunoCAP Rare Allergen Re214, Finch feathers ImmunoCAP Allergen Rf211, Blackberry ImmunoCAP Allergen f253, Pine nut, pignoles ImmunoCAP Allergen Rf303, Halibut ImmunoCAP Allergen wx209, Ambrosia sp. ImmunoCAP Allergen Rf325, Sheep milk ImmunoCAP Allergen Rf222, Tea ImmunoCAP Rare Allergen Rf305, Fenugreek ImmunoCAP Allergen Rw23, Yellow dock ImmunoCAP Rare Allergen Rf277, Dill ImmunoCAP Rare Allergen Rt214, Date ImmunoCAP Allergen Rw82, Careless weed ImmunoCAP Allergen Rf293, Papaya ImmunoCAP Allergen Rrx2, Regional ImmunoCAP Allergen Rf316, Rape seed ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red) ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST ImmunoCAP Rare Allergen Re209, Gerbil epithelium ImmunoCAP Allergen Rgx6, Grass pollen ImmunoCAP Allergen Rf272, Tarragon ImmunoCAP Allergen Rf384, Whitefish (Inconnu) ImmunoCAP Allergen fx71, Spices ImmunoCAP Allergen Rf307, Hake ImmunoCAP Allergen Rf234, Vanilla ImmunoCAP Allergen Rf328, Fig ImmunoCAP Allergen Rm46, Bipolaris ImmunoCAP Allergen Rw204, Sunflower ImmunoCAP Allergen Rf147, Gulf flounder ImmunoCAP Allergen fx74, Fish ImmunoCAP Allergen Rw45, Alfalfa ImmunoCAP Allergen k80, Formaldehyde/Formalin ImmunoCAP Allergen o70, Seminal fluid ImmunoCAP Allergen fx70, Spices ImmunoCAP Allergen Rf212, Mushroom (champignon) ImmunoCAP Allergen Rf270, Ginger ImmunoCAP Allergen Rt56, Bayberry ImmunoCAP Rare Allergen f226, Pumpkin seed ImmunoCAP Allergen Rw46, Dog fennel ImmunoCAP Allergen c7, Cefaclor ImmunoCAP Allergen Rf315, Green bean ImmunoCAP Allergen Rf311, Megrim ImmunoCAP Allergen Rf287, Red kidney bean ImmunoCAP Allergen k83, Cotton seed ImmunoCAP Rare Allergen f294, Passion fruit ImmunoCAP Allergen Rf329, Watermelon BION Cytomegalovirus, IgG, Test System ImmunoCAP Allergen Component rCan f 6 Dog ImmunoCAP Allergen Component rFel d 7 Cat ImmunoCAP Allergen Component rCan f 4 Dog ImmunoCAP Allergen, w1, Common ragweed ImmunoCAP Allergen, f20 Almond BION Borrelia burgdorferi; Antigen Substrate Slides ImmunoCAP Allergen e80, Goat epithelium ImmunoCAP Allergen f26, Pork ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.) ImmunoCAP Allergen m202, Acremonium kiliense (Cephalosporium acremonium) ImmunoCAP Allergen f84, Kiwi fruit ImmunoCAP Allergen e72, Mouse urine proteins ImmunoCAP Allergen f40, Tuna ImmunoCAP Allergen t208, Linden ImmunoCAP Specific IgE Conjugate 100 ImmunoCAP Allergen e76, Mouse serum proteins ImmunoCAP Allergen m205, Trichophyton rubrum ImmunoCAP Allergen f203, Pistachio ImmunoCAP Allergen gx4, Grass pollen ImmunoCAP Allergen f216, Cabbage ImmunoCAP Allergen f2, Milk ImmunoCAP Allergen t23, Italian/Mediterranean/Funeral cypress ImmunoCAP Allergen f96, Avocado ImmunoCAP Allergen e83, Swine epithelium ImmunoCAP Allergen t72, Queen palm ImmunoCAP Allergen wx2, Weed pollen ImmunoCAP Allergen fx1, Food ImmunoCAP Allergen fx16, Fruits ImmunoCAP Allergen f255, Plum ImmunoCAP Allergen f218, Paprika, Sweet pepper ImmunoCAP Allergen f88, Mutton ImmunoCAP Allergen c6, Amoxicilloyl ImmunoCAP Allergen g201, Barley ImmunoCAP Allergen k87, Allergen component nAsp o 21 Alpha-amylase, Aspergillus oryzae ImmunoCAP Allergen f89, Mustard ImmunoCAP Allergen g6, Timothy ImmunoCAP Allergen f37, Blue mussel ImmunoCAP Allergen m2, Cladosporium herbarum ImmunoCAP Allergen f254, Plaice ImmunoCAP Allergen f299, Sweet chestnut ImmunoCAP Allergen g11, Brome grass ImmunoCAP Allergen e71, Mouse epithelium ImmunoCAP Allergen mx1, Moulds ImmunoCAP Allergen d1, House dust mite ImmunoCAP Allergen g8, Meadow grass, Kentucky blue ImmunoCAP Allergen e77, Budgerigar droppings ImmunoCAP Allergen w14, Common pigweed ImmunoCAP Allergen w15, Scale, Lenscale ImmunoCAP Allergen f231, Milk boiled ImmunoCAP Allergen e84, Hamster epithelium ImmunoCAP Allergen t20, Mesquite ImmunoCAP Allergen c73, Insulin human ImmunoCAP Allergen f14, Soybean ImmunoCAP Allergen t1, Box-elder ImmunoCAP Allergen f83, Chicken ImmunoCAP Specific IgE 0-100 ImmunoCAP Allergen g14, Cultivated oat ImmunoCAP Allergen g17, Bahia grass ImmunoCAP Allergen gx3, Grass pollen ImmunoCAP Allergen m11, Rhizopus nigricans ImmunoCAP Allergen tx6, Tree pollen ImmunoCAP Allergen tx9, Tree pollen ImmunoCAP Allergen d70, Storage mite ImmunoCAP Allergen wx5, Weed pollen ImmunoCAP Allergen e85, Chicken feathers ImmunoCAP Specific IgE Negative Control ImmunoCAP Allergen f51, Bamboo shoot ImmunoCAP Allergen f256, Walnut ImmunoCAP Allergen k79, Phthalic anhydride ImmunoCAP Allergen i8, Moth ImmunoCAP Allergen t11, Maple leaf sycamore, London plane ImmunoCAP Allergen f55, Common millet ImmunoCAP Allergen f81, Cheese, cheddar type ImmunoCAP Allergen m16, Curvularia lunata ImmunoCAP Allergen p1, Ascaris ImmunoCAP Allergen w6, Mugwort ImmunoCAP Allergen f215, Lettuce ImmunoCAP Allergen t4, Hazel ImmunoCAP Allergen f7, Oat ImmunoCAP Allergen g10, Johnson grass ImmunoCAP Allergen wx7, Weed pollen ImmunoCAP Allergen f235, Lentil ImmunoCAP Allergen fx25, Food ImmunoCAP Allergen f207, Clam ImmunoCAP Allergen wx6, Weed pollen ImmunoCAP Allergen gx2, Grass pollen ImmunoCAP Allergen e3, Horse dander ImmunoCAP Allergen f1, Egg white ImmunoCAP Allergen f93, Cacao ImmunoCAP Allergen w9, Plantain (English), Ribwort ImmunoCAP Allergen fx20, Food ImmunoCAP Allergen e4, Cow dander ImmunoCAP Allergen d2, House dust mite ImmunoCAP Allergen m15, Trichoderma viride ImmunoCAP Allergen f95, Peach Phadia 250 ImmunoCAP Allergen f232, Allergen component nGal d 2 Ovalbumin, Egg ImmunoCAP Allergen wx3, Weed pollen ImmunoCAP Allergen f3, Fish (cod) ImmunoCAP Allergen k72, Ispaghula ImmunoCAP Allergen ex71, Feathers ImmunoCAP Allergen w13, Cocklebur ImmunoCAP Allergen f80, Lobster ImmunoCAP Allergen t16, White pine ImmunoCAP Allergen f44, Strawberry ImmunoCAP Allergen e73, Rat epithelium ImmunoCAP Allergen e74, Rat urine proteins ImmunoCAP Allergen f48, Onion ImmunoCAP Allergen f75, Egg yolk ImmunoCAP Allergen f13, Peanut ImmunoCAP Allergen w20, Nettle ImmunoCAP Allergen f4, Wheat ImmunoCAP Allergen t6, Mountain juniper ImmunoCAP Allergen t8, Elm ImmunoCAP Allergen f35, Potato ImmunoCAP Allergen g7, Common reed ImmunoCAP Allergen f11, Buckwheat ImmunoCAP Allergen c1, Penicilloyl G ImmunoCAP Specific IgE Anti-IgE ImmunoCAP Allergen i2, White-faced hornet venom ImmunoCAP Allergen g12, Cultivated rye ImmunoCAP Allergen i75, European hornet venom ImmunoCAP Allergen g4, Meadow fescue ImmunoCAP Allergen f25, Tomato ImmunoCAP Allergen f45, Yeast ImmunoCAP Allergen k77, Isocyanate HDI ImmunoCAP Allergen w21, Wall pellitory ImmunoCAP Allergen g3, Cocksfoot ImmunoCAP Allergen f5, Rye ImmunoCAP Allergen d73, Storage mite ImmunoCAP Allergen f41, Salmon ImmunoCAP Allergen m3, Aspergillus fumigatus ImmunoCAP Allergen e87, Rat epithelium, serum and urine proteins ImmunoCAP Allergen f50, Chub mackerel ImmunoCAP Allergen t12, Willow ImmunoCAP Allergen t2, Grey alder ImmunoCAP Allergen f290, Oyster ImmunoCAP Allergen f242, Cherry ImmunoCAP Allergen e70, Goose feathers ImmunoCAP Allergen f31, Carrot ImmunoCAP Allergen f205, Herring ImmunoCAP Allergen w19, Wall pellitory ImmunoCAP Allergen ex70, Rodents ImmunoCAP Allergen w3, Giant ragweed ImmunoCAP Allergen tx5, Tree pollen Phadia 5000 ImmunoCAP Allergen f17, Hazel nut ImmunoCAP Allergen m1, Penicillium chrysogenum ImmunoCAP Allergen wx1, Weed pollen ImmunoCAP Allergen mx2, Moulds ImmunoCAP Specific IgE Curve Controls ImmunoCAP Allergen f204, Trout ImmunoCAP Allergen f33, Orange ImmunoCAP Allergen f15, White bean ImmunoCAP Allergen f60, Jack mackerel, Scad Dilution Well ImmunoCAP Allergen f202, Cashew nut ImmunoCAP Allergen t18, Eucalyptus, Gum-tree ImmunoCAP Allergen f59, Octopus ImmunoCAP Allergen fx3, Food ImmunoCAP Allergen m12, Aureobasidium pullulans Phadia 1000 ImmunoCAP Allergen m14, Epicoccum purpurascens ImmunoCAP Allergen m7, Botrytis cinerea ImmunoCAP Allergen gx1, Grass pollen ImmunoCAP Allergen e75, Rat serum proteins ImmunoCAP Allergen o1, Cotton, crude fibers ImmunoCAP Allergen i70, Fire ant ImmunoCAP Allergen f18, Brazil nut ImmunoCAP Allergen f6, Barley ImmunoCAP Allergen f77, Allergen component nBos d 5 Beta-lactoglobulin, Milk ImmunoCAP Allergen w2, Western ragweed ImmunoCAP Allergen g1, Sweet vernal grass ImmunoCAP Allergen t210, Privet ImmunoCAP Allergen f245, Egg ImmunoCAP Allergen e201, Canary bird feathers ImmunoCAP Allergen t3, Common silver birch ImmunoCAP Allergen f58, Pacific squid ImmunoCAP Allergen m8, Setomelanomma rostrata (Helminthosporium halodes) ImmunoCAP Allergen g15, Cultivated wheat ImmunoCAP Allergen f61, Sardine, Pilchard ImmunoCAP Allergen fx24, Food Washing Solution Concentrate ImmunoCAP Specific IgE Calibrator Strip 0-100 ImmunoCAP Allergen h2, House dust (Hollister-Stier Labs.) ImmunoCAP Allergen d72, Storage mite ImmunoCAP Allergen fx7, Food Washing Solution Additive ImmunoCAP Allergen f76, Allergen component nBos d 4 Alpha-lactalbumin, Milk ImmunoCAP Allergen tx4, Tree pollen ImmunoCAP Allergen f210, Pineapple ImmunoCAP Allergen f94, Pear ImmunoCAP Allergen c5, Ampicilloyl ImmunoCAP Allergen w12, Goldenrod ImmunoCAP Allergen t14, Cottonwood ImmunoCAP Allergen tx8, Tree pollen ImmunoCAP Allergen i6, Cockroach, German ImmunoCAP Allergen f9, Rice ImmunoCAP Allergen f237, Apricot ImmunoCAP Allergen f78, Allergen component nBos d 8 Casein, Milk ImmunoCAP Allergen w7, Marguerite, Ox-eye daisy ImmunoCAP Allergen f90, Malt ImmunoCAP Allergen f85, Celery ImmunoCAP Allergen fx13, Vegetables Development Solution ImmunoCAP Allergen f10, Sesame seed ImmunoCAP Allergen f47, Garlic ImmunoCAP Allergen w16, Rough marshelder ImmunoCAP Allergen g202, Maize, Corn ImmunoCAP Allergen k75, Isocyanate TDI ImmunoCAP Allergen m9, Fusarium proliferatum ImmunoCAP Allergen k84, Sunflower seed ImmunoCAP Phadiatop ImmunoCAP Allergen f280, Black pepper ImmunoCAP Allergen fx73, Meat ImmunoCAP Allergen f12, Pea ImmunoCAP Allergen f233, Allergen component nGal d 1 Ovomucoid, Egg ImmunoCAP Allergen e82, Rabbit epithelium ImmunoCAP Allergen i76, Berlin beetle Phadia 2500 ImmunoCAP Allergen g16, Meadow foxtail ImmunoCAP Allergen i73, Blood worm ImmunoCAP Allergen k78, Ethylene oxide ImmunoCAP Allergen f259, Grape ImmunoCAP Allergen e1, Cat dander ImmunoCAP Allergen fx14, Vegetables ImmunoCAP Allergen m207, Aspergillus niger ImmunoCAP Allergen f8, Maize, Corn ImmunoCAP Allergen f79, Gluten ImmunoCAP Allergen f244, Cucumber ImmunoCAP Allergen p4, Anisakis ImmunoCAP Allergen d74, House dust mite ImmunoCAP Allergen f36, Coconut ImmunoCAP Allergen k76, Isocyanate MDI ImmunoCAP Allergen e86, Duck feathers ImmunoCAP Allergen e89, Turkey feathers ImmunoCAP Allergen i71, Mosquito ImmunoCAP Allergen m13, Phoma betae ImmunoCAP Allergen m5, Candida albicans ImmunoCAP Allergen g9, Redtop, Bentgrass ImmunoCAP Allergen e6, Guinea pig epithelium ImmunoCAP Allergen c2, Penicilloyl V ImmunoCAP Allergen d3, House dust mite ImmunoCAP Allergen f27, Beef ImmunoCAP Allergen w8, Dandelion ImmunoCAP Allergen t70, Mulberry ImmunoCAP Allergen e88, Mouse epithelium, serum and urine proteins ImmunoCAP Allergen t5, American beech ImmunoCAP Allergen m10, Stemphylium herbarum ImmunoCAP Allergen m81, Staphylococcal enterotoxin B ImmunoCAP Allergen g71, Canary grass ImmunoCAP Allergen fx2, Food ImmunoCAP Allergen m6, Alternaria alternata ImmunoCAP Allergen fx15, Fruits ImmunoCAP Allergen c74, Gelatin bovine ImmunoCAP Allergen m80, Staphylococcal enterotoxin A ImmunoCAP Allergen f92, Banana ImmunoCAP Specific IgE Curve Control Strip ImmunoCAP Allergen f201, Pecan nut ImmunoCAP Allergen t22, Pecan, Hickory ImmunoCAP Allergen f91, Mango ImmunoCAP Allergen t73, Australian pine ImmunoCAP Allergen ex2, Animal proteins ImmunoCAP Allergen w17, Firebush (Kochia) ImmunoCAP Allergen d71, Storage mite ImmunoCAP Allergen f208, Lemon ImmunoCAP Allergen i1, Honey bee venom ImmunoCAP Allergen f213, Rabbit ImmunoCAP Allergen ex1, Animal proteins ImmunoCAP Allergen tx7, Tree pollen ImmunoCAP Allergen g13, Velvet grass ImmunoCAP Allergen fx5, Food ImmunoCAP Allergen e5, Dog dander Washing Solution Phadia Information Data Manager Software Package ImmunoCAP Allergen t10, Walnut ImmunoCAP Allergen t17, Japanese cedar ImmunoCAP Allergen f284, Turkey meat ImmunoCAP Allergen f86, Parsley Stop Solution ImmunoCAP Allergen g5, Rye-grass ImmunoCAP Allergen f82, Cheese, mold type ImmunoCAP Allergen t15, White ash ImmunoCAP Allergen hx2, House dust ImmunoCAP Allergen t19, Acacia ImmunoCAP Allergen f24, Shrimp ImmunoCAP Allergen g2, Bermuda grass ImmunoCAP Allergen f49, Apple ImmunoCAP Allergen f214, Spinach ImmunoCAP Allergen w5, Wormwood ImmunoCAP Allergen w11, Saltwort (prickly), Russian thistle ImmunoCAP Allergen f260, Broccoli ImmunoCAP Allergen k81, Ficus spp. ImmunoCAP Allergen t7, Oak ImmunoCAP Allergen f23, Crab ImmunoCAP Allergen f225, Pumpkin ImmunoCAP Allergen t9, Olive ImmunoCAP Allergen w10, Goosefoot, Lamb's quarters ImmunoCAP Allergen e81, Sheep epithelium ImmunoCAP Allergen i5, Yellow hornet venom ImmunoCAP Allergen f54, Sweet potato ImmunoCAP Specific IgE Conjugate 400 ImmunoCAP Allergen w4, False ragweed ImmunoCAP Allergen g70, Wild rye grass ImmunoCAP Allergen f87, Melon ImmunoCAP Allergen m4, Mucor racemosus ImmunoCAP Allergen t21, Melaleuca, Cajeput-tree ImmunoCAP Allergen e78, Budgerigar feathers ImmunoCAP Allergen w18, Sheep sorrel ImmunoCAP Allergen fx18, Food ImmunoCAP Allergen tx1, Tree pollen ImmunoCAP Allergen f56, Foxtail millet ImmunoCAP Allergen f209, Grapefruit EliA Cardiolipin IgA Immunoassay EliA Ro52 EliA Ro60 ImmunoCAP Allergen t225, Allergen component rBet v6 Birch ImmunoCAP Allergen t220, Allergen component rBet v 4 Birch ImmunoCAP Allergen t216, Allergen component rBet v 2 Profili ImmunoCAP Allergen g205, Allergen component rPhl p 1 Timothy ImmunoCAP Allergen f428, Allergen component rCor a 1 PR-10 H ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profil ImmunoCAP Allergen t215, Allergen component rBet v 1 PR-10, ImmunoCAP Allergen f425, Allergen component rCor a 8, Hazel ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timoth ImmunoCAP Allergen g209, Allergen component rPhl p 6 Timothy ImmunoCAP Allergen g206, Allergen component rPhl p 2 Timothy ImmunoCAP Allergen g210, Allergen component rPhl p 7 Timothy Dilution Plate, Phadia 250 EliA CCP Positive Control 250 EliA Sample Diluent EliA Dummy Well EliA IgG Calibrator Well EliA CCP Well EliA CCP Positive Control 2500/5000 EliA IgG Curve Control Strips EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA IgG Calibrator Strips BION MEASLES-G IFA TEST SYSTEM BION PBS IFA BUFFER EliA ß2-Glycoprotein I IgA BION INFLUENZA A IFA SLIDES; BION INFLUENZA B IFA SLIDES ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Phadia 250, Phadia 2500, and Phadia 5000 Instruments BION ADENOVIRUS IFA SLIDES AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000) ImmunoCAP Allergen i209, Allergen component rVes v 5 Common wasp ImmunoCAP Allergen i210, Allergen component rPol d 5 European Paper wasp ImmunoCAP Allergen i211, Allergen component rVes v 1 Phospholipase A1 Common wasp ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee ImmunoCAP Allergen Component MUXF3 CCD, Bromelain ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee ImmunoCAP Allergen i208, Allergen component rApi m 1 Phospholipase A2 Honeybee ImmunoCAP Allergen f98, Gliadin EliA™ PR3S Immunoassay EliA™ ANCA/GBM Positive Control 250 EliA™ MPOS Immunoassay EliA™ GBM Immunoassay EliA IgA Curve Control Strips EliA Celikey IgA Well EliA IgA Calibrator Strips EliA IgA Calibrator Well EliA IgA Conjugate 200 EliA IgA Conjugate 50 HELMED HTC BION Direct Identification; Control Slides ImmunoCAP Allergen w233, Allergen component nArt v 3, LTP, Mugwort ImmunoCAP Allergen e228, Allergen Component rFel d 4, Cat ImmunoCAP Allergen e227, Allergen Component rEqu c 1, Horse ImmunoCAP Allergen f419, Allergen component rPru p 1, PR-10, Peach ImmunoCAP Allergen w231, Allergen component nArt v 1, Mugwort ImmunoCAP Allergen f354, Allergen component rBer e 1, Brazil nut ImmunoCAP Allergen f421, Allergen component rPru p 4, Profilin, Peach ImmunoCAP Allergen f351, Allergen component rPen a 1, Tropomyosin, Shrimp ImmunoCAP Allergen f420, Allergen component rPru p 3, LTP, Peach

Establishment Types

Complaint File Establishment per 21 CFR 820.198