FDA-Device2018-08-29Class III
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Euro Diagnostica AB
Hazard
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Sold states
MN
Affected count
4
Manufactured in
Box 50117, Lundavagen 151, Malmo, Sweden
Products
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2919-2018Don't want to check this manually?
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