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Phadia US Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2041-2023Class IIPhadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies May 1, 2023
Z-2040-2023Class IIEliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IMay 1, 2023
Z-1107-2021Class IIEliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodieDecember 14, 2020
Z-1312-2018Class IIImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vDecember 18, 2017
Z-1313-2018Class IIImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an iDecember 18, 2017
Z-0387-2018Class IIPhadia 1000 Instrument, Article Number 12-3800-01.July 5, 2017
Z-1253-2017Class IIEliA Sample Diluent, Article number, 83-1023-01January 30, 2017
Z-0947-2015Class IIPhadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument softwNovember 20, 2014
Z-2285-2012Class IIIPHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibAugust 2, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K141375ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250February 13, 2015
K140225ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 1October 27, 2014
K132631EIA SMDP IMMUNOASSAYAugust 29, 2014
K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYDecember 23, 2013
K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESAugust 28, 2013
K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLESeptember 13, 2012
K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYJune 22, 2012
DEN120001IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP,February 15, 2012
K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSDecember 22, 2011
K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMSeptember 30, 2011
K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01August 13, 2010
K091845CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMJune 7, 2010
K092978IMMUNOCAP RAPID READER, MODEL 12-3600-10January 19, 2010
K083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-550May 28, 2009
K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYApril 10, 2009
K083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596March 13, 2009
K072149ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01January 15, 2008
K072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01December 7, 2007
K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPNovember 20, 2007
K063775ELIA GLIADIN IGA, IGG AND CELIAC CONTROLMarch 14, 2007