Phadia US, Inc.
Phadia US, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2015, with 9 FDA device recalls on record.
Top product codes for Phadia US, Inc.
FDA recalls by Phadia US, Inc.
- Z-2041-2023 — 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 disease Material Number 12410002
- Z-2040-2023 — 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 plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901
- Z-1107-2021 — 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). Material Number: 14-5500-01
- Z-1312-2018 — 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 instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
- Z-1313-2018 — 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 be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
- Z-0387-2018 — Phadia 1000 Instrument, Article Number 12-3800-01.
- Z-1253-2017 — EliA Sample Diluent, Article number, 83-1023-01
- Z-0947-2015 — 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 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
- Z-2285-2012 — PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Phadia US, Inc.
- K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
- K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
- K132631 — EIA SMDP IMMUNOASSAY
- K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
- K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
- K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
- K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
- DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
- K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
- K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
- K092978 — IMMUNOCAP RAPID READER, MODEL 12-3600-10
- K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596
- K072149 — ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
- K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
- K072661 — IMMUNOCAP THYRLOBULIN IMMUNOCAP
- K063775 — ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
- K062787 — ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01
- K062583 — ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.