FDA-Device2023-07-05Class II
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
Phadia US Inc
Hazard
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Sold states
US: CA, NJ, MI
Affected count
9 units
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2041-2023Don't want to check this manually?
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