Phadia US Inc
FDA Regulatory Profile
Phadia US Inc appears in FDA public data with 9 recalls, 22 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2041-2023, Class II) was initiated on May 1, 2023. Its most recent 510(k) clearance was granted on February 13, 2015.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 22
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2041-2023 | Class II | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies | May 1, 2023 |
| Z-2040-2023 | Class II | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP I | May 1, 2023 |
| Z-1107-2021 | Class II | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodie | December 14, 2020 |
| Z-1312-2018 | Class II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in v | December 18, 2017 |
| Z-1313-2018 | Class II | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an i | December 18, 2017 |
| Z-0387-2018 | Class II | Phadia 1000 Instrument, Article Number 12-3800-01. | July 5, 2017 |
| Z-1253-2017 | Class II | EliA Sample Diluent, Article number, 83-1023-01 | January 30, 2017 |
| Z-0947-2015 | Class II | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument softw | November 20, 2014 |
| Z-2285-2012 | Class III | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antib | August 2, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | February 13, 2015 |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 1 | October 27, 2014 |
| K132631 | EIA SMDP IMMUNOASSAY | August 29, 2014 |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | December 23, 2013 |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | August 28, 2013 |
| K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | September 13, 2012 |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | June 22, 2012 |
| DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, | February 15, 2012 |
| K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | December 22, 2011 |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | September 30, 2011 |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 | August 13, 2010 |
| K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | June 7, 2010 |
| K092978 | IMMUNOCAP RAPID READER, MODEL 12-3600-10 | January 19, 2010 |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-550 | May 28, 2009 |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | April 10, 2009 |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | March 13, 2009 |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | January 15, 2008 |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | December 7, 2007 |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | November 20, 2007 |
| K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | March 14, 2007 |