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AccuDiag ™

Diagnostic Automation, Inc. · Model DACD-2556-2 · UDI-DI 00894175000220

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Description

AccuDiag ™ SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA). A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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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.