FDA-Device2021-02-17Class II
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
Phadia US Inc
Hazard
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Sold states
US Nationwide distribution.
Affected count
365 kits US
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2021Don't want to check this manually?
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