Data / Medical devices / United States / Phadia Us Inc.
Phadia Us Inc.: FDA-registered device maker in Portage, MI, United States, 60 510(k) clearances
Phadia Us Inc. is registered with the FDA (registration 3004973408) in Portage, MI, United States. It lists 52 device types. The FDA files 60 510(k) clearances under its listings, the newest dated June 25, 2026. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004973408
- Address
- 4169 Commercial Ave., Portage, MI, United States, 49002
- Owner or operator
- PHADIA AB (9004441)
- Roles
- Complaint file establishment
- First device listed
- July 1, 1998
- Registered through
- 2026
- Brand names listed
- AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000), AESKUSLIDES® ANCA, AESKUSLIDES® nDNA (Crithidia luciliae), 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, ANA Conjugate, BION ADENOVIRUS IFA SLIDES and more
Devices it lists
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 |
| December 18, 2018 | K182747 | EliA RF IgM Immunoassay | DHR | 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 23, 2018 | K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | MOB | Substantially Equivalent | Aesku.Diagnostics GmbH & Co. KG | 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 |
| February 16, 2018 | K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | LSW | Substantially Equivalent | Aesku.Diagnostics GmbH & Co. KG | accessdata.fda.gov |
| May 5, 2017 | K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| July 28, 2016 | K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | DHN | Substantially Equivalent | Aesku Systems GmbH&Co.Kg | 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 |
| 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 |
| April 5, 1990 | K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | LSR | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 24, 1989 | K894622 | VARICELLA ZOSTER VIRUS | GQW | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 16, 1989 | K894624 | MUMPS VIRUS | GRA | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 16, 1989 | K894623 | RESPIRATORY SYNCYTIAL VIRUS | LKT | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 31, 1989 | K891785 | BION EBV-G (VCA) TEST SYSTEM | JRY | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 15, 1989 | K894625 | CHLAMYDIA (LGV-1) | LKI | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| July 14, 1989 | K893240 | BION EBV-M (VCA) TEST SYSTEM | LJN | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| February 17, 1989 | K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | LJG | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| June 7, 1988 | K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | GQO | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| June 3, 1988 | K880679 | BION CMV-G TEST SYSTEM | GQH | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 17, 1987 | K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | DHN | Substantially Equivalent | Bion Ent., Ltd. | 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 1, 2023 | 92365 | Class II | Ongoing | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or pla | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument | accessdata.fda.gov |
| December 18, 2017 | 79444 | Class II | Terminated | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrume | The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | accessdata.fda.gov |
| July 5, 2017 | 78752 | Class II | Terminated | Phadia 1000 Instrument, Article Number 12-3800-01. | The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. | accessdata.fda.gov |
| January 30, 2017 | 76343 | Class II | Terminated | EliA Sample Diluent, Article number, 83-1023-01 | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate. | accessdata.fda.gov |
| November 20, 2014 | 69872 | Class II | Terminated | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 i | During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run. | accessdata.fda.gov |
| August 2, 2012 | 62572 | Class III | Terminated | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. | accessdata.fda.gov |
| January 3, 2012 | 60513 | Not yet classified | Terminated | ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen | The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o.1 kUA/L). | accessdata.fda.gov |
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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.