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QMedix™

Diagnostic Automation, Inc. · Model DACD 351010 · UDI-DI 00850054026798

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Facilities

Description

QMedix™ FTA-ABS (Syphilis) IFA Kit 10x10 wells 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.