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AccuDiag ™

Diagnostic Automation, Inc. · Model DACD 500100-500 · UDI-DI 00894175000077

GMQ
10
510(k) clearances
35
Adverse events
0
Recalls
17
Facilities

Description

AccuDiag ™ RPR Latex Test Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. 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.