FDA-Device2018-08-29Class III
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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 qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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-2922-2018Don't want to check this manually?
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