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AccuDiag ™

Diagnostic Automation, Inc. · Model DACD-351010 · UDI-DI 00894175000008

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Description

AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent Immunoassay Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

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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.