PHADIA AB

FDA Device Registration & Listing · UPPSALA, SE · Registration 9610566

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610566
FEI Number
3002807876
Entity Name
PHADIA AB
City/State/Country
UPPSALA, SE
Establishment Address
RAPSGATAN 7P, UPPSALA SE-751 37, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
PHADIA AB (Owner Number: 9004441)
Owner / Operator Contact Address
Rapsgatan 7P, P.O. Box 6460, UPPSALA, SE-C 75137, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

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 EliA RF IgM Immunoassay Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E ImmunoCAP Allergen, f20 Almond EliA™ PR3S Immunoassay EliA™ ANCA/GBM Positive Control 250 EliA™ MPOS Immunoassay EliA™ GBM Immunoassay EliA™ M2 Immunoassay EliA™ M2 Positive Control 250 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 EliA Stool Extraction Kit plus 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 EliA Gliadin DP IgA Well EliA Gliadin DP IgG Well Phadia Prime Phadia 250 and Phadia 2500, Phadia 5000 Instrument E series EliA Rib-P ImmunoCAP Allergen Component rCan f 6 Dog ImmunoCAP Allergen Component rFel d 7 Cat ImmunoCAP Allergen Component rCan f 4 Dog ImmunoCAP Specific IgE Control H ImmunoCAP Specific IgE Control L ImmunoCAP Specific IgE Control M 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 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 EliA Stool Extraction Buffer plus ImmunoCAP Tryptase Curve Control Strip ImmunoCAP Tryptase Conjugate 50 ImmunoCAP Tryptase Calibrator Strip 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 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 Phadia Maintenance Solution Large Phadia Maintenance Solution Small 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 Allergen i4, Paper wasp venom ImmunoCAP Allergen i3, common wasp venom (Yellow Jacket) EliA Cardiolipin IgA Immunoassay EliA CENP Immunoassay EliA RNP70 Immunoassay EliA U1RNP Immunoassay Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA™ Scl-70S 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 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 Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA IgG Curve Control Strips EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA IgG Calibrator Strips EliA SmDP-S ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut EliA Celiac Positive Control 250 EliA M2 Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E ImmunoCAP Allergen d202, Allergen component rDer p 1, House dust mite 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 La EliA Ro EliA CENP EliA U1RNP 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, w1, Common ragweed EliA Beta 2-Glycoprotein I IgA EliA Cardiolipin IgA Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E ImmunoCAP Allergen d201, House dust mite EliA ß2-Glycoprotein I IgA EliA MPOs Immunoassay EliA PR3s Immunoassay EliA GBM Immunoassay Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E ImmunoCAP Allergen f338 Phadia 2500+ LAS Connector ImmunoCAP Dummy ImmunoCAP EliA Ro52 EliA Ro60 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 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Phadia 250, Phadia 2500, and Phadia 5000 Instruments ImmunoCAP Allergen, k82 Latex EliA Jo-1 EliA RNP70 EliA ANA Positive Control 250 EliA dsDNA Well 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 ImmunoCAP Tryptase Anti-Tryptase ImmunoCAP Tryptase Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2010-06-10
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-06-10
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2010-06-10
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2019-07-19
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-08-29
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) Immunology Class 2 866.5660 2014-11-04
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2014-11-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-11-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2015-02-17
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2015-02-17
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2008-02-04
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2026-02-06
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-06-07
MST Antibodies, Gliadin Immunology Class 2 866.5750 2010-08-16
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2016-02-01
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2016-02-01
MQA Anti-Ribosomal P Antibodies Immunology Class 2 866.5100 2021-09-14
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2019-05-17
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2013-07-22
PUW System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens Immunology Class 2 866.5750 2019-05-20
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2012-01-10
KEM Agent, Clearing Pathology Class 1 864.4010 2026-02-06
OYL Tryptase Assay System Immunology Class 2 866.5760 2018-03-07
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2013-09-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-03-30
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2016-03-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2005-08-23
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2015-12-15
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2015-02-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-12-27
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2013-12-27
LKO Anti-Rnp Antibody, Antigen And Control Immunology Class 2 866.5100 2019-07-19
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2019-07-19
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2014-11-04
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2010-01-19
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2006-10-11
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2021-07-15
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2018-04-23
MST Antibodies, Gliadin Immunology Class 2 866.5750 2007-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-04-11
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2018-07-27
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2016-04-07
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2009-05-28
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2009-04-15
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2022-11-22
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2017-05-08
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2018-07-27
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2018-07-27
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-12-11
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2012-06-29
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2018-03-14
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) Immunology Class 2 866.5660 2018-03-14
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2008-01-24
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2023-02-01
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2022-09-07
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2022-03-30
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2020-05-04
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2013-02-11
LKO Anti-Rnp Antibody, Antigen And Control Immunology Class 2 866.5100 2009-06-04
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2009-06-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-02-04
LSW Anti-Dna Antibody, Antigen And Control Immunology Class 2 866.5100 2008-02-04
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2012-12-05
OYL Tryptase Assay System Immunology Class 2 866.5760 2012-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Carla Krause Business: Phadia US Inc. Email: carla.krause@thermofisher.com Phone: (616) 2864138

Related Public Records

Same Entity

PHADIA AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9680745 PHADIA GMBH FREIBURG Baden-Wurttemberg, DE
3039353646 PHADIA AB Uppsala, SE
3004973408 PHADIA US INC. Portage, MI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K874883 Incstar Corp. WALNUT ALLERGEN DISC 1988-05-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2008 Louisville Apl Diagnostics Inc 2
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Z-0003-2013 Beckman Coulter Inc. 2
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610566. Last updated year: 2026. Please use registration number 9610566 when referencing this establishment in official correspondence.
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