Data / Medical devices / Sweden / Phadia AB

Phadia AB: FDA-registered device maker in Uppsala, Sweden, 51 510(k) clearances

Name: Phadia AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Phadia AB is registered with the FDA (registration 9610566) in Uppsala, Sweden. It lists 30 device types. The FDA files 51 510(k) clearances under its listings, the newest dated June 25, 2026. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 9610566
FEI number: 3002807876
Address: Rapsgatan 7P, Uppsala, Sweden, SE-751 37
Owner or operator: PHADIA AB (9004441)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: August 23, 2005
Registered through: 2026
Brand names listed: AESQC® ANA HEp-2 Centromere; AESQC® ANA HEp-2 Cytoplasmic; AESQC® ANA HEp-2 Homogeneous, AESQC® ANA HEp-2 Nucleolar; AESQC® ANA HEp-2 Panel 1; AESQC® ANA HEp-2 Speckled; AESQC® IFA Negative Control, AESQC® Pool 1; AESQC® Pool 2; AESQC® Pool 3; AESQC® Pool 4; AESQC® Pool 5; AESQC® Pool Mix, Development Solution, Dilution Plate, Phadia 250, Dilution Well, ELIA CELIKEY IGG WELL, EliA ANA 3 Positive Control 250 and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Clearing	KEM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer, Specification developer	accessdata.fda.gov
Anti-Dna Antibody, Antigen And Control	LSW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Anti-Ribosomal P Antibodies	MQA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Anti-Rnp Antibody, Antigen And Control	LKO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Anti-Sm Antibody, Antigen And Control	LKP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody	NYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)	MVM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	MVJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Radioallergosorbent (Rast) Immunological	DHB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens	PUW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tryptase Assay System	OYL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 25, 2026	K253367	EliA CTD 13 Screen	LLL	Substantially Equivalent	Phadia AB	accessdata.fda.gov
August 3, 2022	K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
July 27, 2022	K210902	EliA Ro52, EliA Ro60	LKJ	Substantially Equivalent	Phadia AB	accessdata.fda.gov
September 13, 2021	K202541	EliA RNA Pol III	NYO	Substantially Equivalent	Phadia AB	accessdata.fda.gov
September 13, 2021	K202540	EliA Rib-P	MQA	Substantially Equivalent	Phadia AB	accessdata.fda.gov
July 14, 2021	K202067	EliA SmDP-S	LKP	Substantially Equivalent	Phadia AB	accessdata.fda.gov
May 1, 2020	K200279	ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
November 29, 2019	K190710	EliA SymphonyS Immunoassay	LLL	Substantially Equivalent	Phadia AB	accessdata.fda.gov
May 14, 2019	K190315	ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 1, 2019	K181871	EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay	MVM	Substantially Equivalent	Phadia AB	accessdata.fda.gov
December 18, 2018	K182747	EliA RF IgM Immunoassay	DHR	Substantially Equivalent	Phadia AB	accessdata.fda.gov
November 27, 2018	K182353	EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay	LJM	Substantially Equivalent	Phadia AB	accessdata.fda.gov
July 13, 2018	K181556	EliA M2 Immunoassay	DBM	Substantially Equivalent	Phadia AB	accessdata.fda.gov
June 25, 2018	K181329	EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay	MSV	Substantially Equivalent	Phadia AB	accessdata.fda.gov
April 16, 2018	K173726	ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 13, 2018	K173792	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay	MOB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 2, 2018	K173704	ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip	OYL	Substantially Equivalent	Phadia AB	accessdata.fda.gov
May 5, 2017	K163370	ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 25, 2016	K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000	JZO	Substantially Equivalent	Phadia AB	accessdata.fda.gov
February 29, 2016	K150597	ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
January 19, 2016	K151029	Phadia Prime	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
December 14, 2015	K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
February 13, 2015	K141375	ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250	DBM	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
October 30, 2014	K140493	ELIA SCL-70S IMMUNOASSAY	LJM	Substantially Equivalent	Phadia GmbH	accessdata.fda.gov
October 27, 2014	K140225	ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO	MOB	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
February 24, 2014	K133404	IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH	DGC	Substantially Equivalent	Phadia AB	accessdata.fda.gov
December 23, 2013	K131821	ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY	MID	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
August 28, 2013	K122197	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES	DHB	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
July 10, 2013	K131738	IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
June 28, 2013	K123275	IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 13, 2013	K121156	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
January 29, 2013	K121463	IMMUNOCAP ALLERGEN K82	DHB	Substantially Equivalent	Thermo Fisher Scientific	accessdata.fda.gov
September 13, 2012	K113841	IMMUNOCAP ALLERGEN COMPONENTS BUNDLE	DHB	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
June 22, 2012	K112414	ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY	MSV	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
February 15, 2012	DEN120001	IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE	OYL	Unknown	Phadia US, Inc.	accessdata.fda.gov
December 22, 2011	K111919	IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS	DHB	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
September 30, 2011	K102673	RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM	DHR	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
May 27, 2011	K101251	IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
December 15, 2010	K100999	IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
August 13, 2010	K093459	ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01	MST	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
June 7, 2010	K091845	CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM	MID	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
November 20, 2009	K092050	IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
May 28, 2009	K083117	ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01	LKO	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
April 10, 2009	K082759	ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY	LKJ	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
December 7, 2007	K072393	ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01	LSW	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
August 24, 2007	K071913	IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01	DHB	Substantially Equivalent	Phadia AB	accessdata.fda.gov
March 14, 2007	K063775	ELIA GLIADIN IGA, IGG AND CELIAC CONTROL	MST	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
December 29, 2006	K062787	ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01	MVM	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
December 26, 2006	K062583	ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01	MVM	Substantially Equivalent	Phadia US, Inc.	accessdata.fda.gov
August 3, 2006	K061165	ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01	NHX	Substantially Equivalent	Sweden Diagnostics (Us), Inc.	accessdata.fda.gov
June 9, 2005	K051218	MODIFICATION TO: UNICAP SPECIFIC IGE	DHB	Substantially Equivalent	Pharmacia Diagnostics AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 24, 2023	93403	Class II	Ongoing	EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic	Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.	accessdata.fda.gov
December 14, 2020	87161	Class II	Terminated	EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE).	Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).	accessdata.fda.gov
July 9, 2019	83402	Class II	Terminated	Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and r	code 7-102 Liquid Sensor Error	accessdata.fda.gov
May 10, 2019	82979	Class II	Terminated	EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in	Potential for reporting low assay results	accessdata.fda.gov
November 20, 2017	79438	Class II	Terminated	Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including	We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).	accessdata.fda.gov
December 28, 2015	72969	Class II	Terminated	EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the cl	All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.	accessdata.fda.gov

Compare with other makers

Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.