Company ยท US
Phadia US, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2015. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 8 |
| MST | Antibodies, Gliadin | 4 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| LSW | Anti-Dna Antibody, Antigen And Control | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
| MVU | Reagents, Specific, Analyte | 1 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 1 |
| OYL | Tryptase Assay System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2015 | K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 Phadia US, Inc., DE | DBM |
| Oct 27, 2014 | K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO Phadia US, Inc., DE | MOB |
| Aug 29, 2014 | K132631 | EIA SMDP IMMUNOASSAY Phadia US, Inc. | LKP |
| Dec 23, 2013 | K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY Phadia US, Inc. | MID |
| Aug 28, 2013 | K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia US, Inc. | DHB |
| Sep 13, 2012 | K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE Phadia US, Inc. | DHB |
| Jun 22, 2012 | K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY Phadia US, Inc. | MSV |
| Feb 15, 2012 | DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE Phadia US, Inc. | OYL |
| Dec 22, 2011 | K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS Phadia US, Inc. | DHB |
| Sep 30, 2011 | K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM Phadia US, Inc. | DHR |
| Aug 13, 2010 | K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 Phadia US, Inc. | MST |
| Jun 7, 2010 | K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM Phadia US, Inc. | MID |
| Jan 19, 2010 | K092978 | IMMUNOCAP RAPID READER, MODEL 12-3600-10 Phadia US, Inc. | DHB |
| 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 Phadia US, Inc. | LKO |
| Apr 10, 2009 | K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY Phadia US, Inc. | LKJ |
| Mar 13, 2009 | K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 Phadia US, Inc. | LJM |
| Jan 15, 2008 | K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 Phadia US, Inc. | LLL |
| Dec 7, 2007 | K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 Phadia US, Inc. | LSW |
| Nov 20, 2007 | K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP Phadia US, Inc. | JNL |
| Mar 14, 2007 | K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL Phadia US, Inc. | MST |
| Dec 29, 2006 | K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. | MVM |
| Dec 26, 2006 | K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 Phadia US, Inc. | MVM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2023 | Phadia US Inc Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di Open, Classified |
MST | K093459 |
| Jun 30, 2023 | Phadia US Inc 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 i Open, Classified |
MST | K093459 |
| Feb 11, 2021 | Phadia US Inc 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 Terminated |
LSW | K072393 |
| Dec 18, 2017 | Phadia US Inc ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016).
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to b Terminated |
DHB | K051218 K993388 |
| Dec 18, 2017 | Phadia US Inc 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 Terminated |
DHB | K051218 K993388 |
| Jul 5, 2017 | Phadia US Inc Phadia 1000 Instrument, Article Number 12-3800-01. Terminated |
DHB | K133404 K161899 |
| Feb 24, 2017 | Phadia US Inc EliA Sample Diluent, Article number, 83-1023-01 Terminated |
NHX | K061165 |
| Jan 12, 2015 | Phadia US Inc 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 Terminated |
DHB | K121156 K121463 +4 |
| Aug 28, 2012 | Phadia US Inc PHADIA Varelisa Cardiolipin IgM
Cardiolipin autoantibody immunological test system (IgM class antibodies) Terminated |
MID | K020758 |
| Feb 17, 2012 | Phadia US Inc 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 Terminated |
MVU | None listed |