9 results
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42ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 21, 2015
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA Enforcement
Class III
·Terminated·Phadia US Inc·September 5, 2012
EliA Sample Diluent, Article number, 83-1023-01
FDA Enforcement
Class II
·Terminated·Phadia US Inc·March 8, 2017
Phadia 1000 Instrument, Article Number 12-3800-01.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 24, 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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·April 11, 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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·April 11, 2018
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
FDA Enforcement
Class II
·Ongoing·Phadia US Inc·July 5, 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
FDA Enforcement
Class II
·Ongoing·Phadia US Inc·July 5, 2023
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
FDA Enforcement
Class II
·Terminated·Phadia US Inc·February 17, 2021