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Anti-nRNP/Sm ELISA (IgG)

EUROIMMUN Medizinische Labordiagnostika AG · Model EA 1591-9601 G · UDI-DI 04049016027010

LKO
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Recalls

DateFirmReason
2016-10-21Euro Diagnostica ABIncorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.