RegulatoryAlerts Logo
RegulatoryAlerts
InsightsBlogPricingSign InStart Free Trial
All WHO updates
WHO
REGULATORY UPDATE
New addition to WHO's list of prequalified IVDs: Determine™ Syphilis Advanced
Published: 9/16/2026Detected: 7/1/2026

Summary preview

Adds the Determine™ Syphilis Advanced point-of-care immunoassay to WHO’s list of prequalified IVDs for qualitative detection of Treponema pallidum antibodies in whole blood, plasma, or serum.

Get the full analysis, free

Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.

Create free account
infectious_disease
pediatrics
#WHO prequalification
#IVD
#point-of-care immunoassay
#Treponema pallidum
#syphilis diagnosis

Official Source Document
Source Verified

Access the original document directly from WHO.

View Official Document

More from WHO

  • New Deadline for Submission: Request for Quotations (RFQ) from interested Notified Bodies - WHO Prequalification Assessment for Medical Devices10/2/2026
  • PQT/AMD newsletter - Q3 2026, Issue 54 is now available10/2/2026
  • PQ Webinar: Launch of WHO Prequalification of Medical Devices10/2/2026
  • New EUL listing10/2/2026
  • Prequalification of In Vitro Diagnostics: Scope Expansion10/2/2026

Get WHO alerts in your inbox as they are published.

Free plan, 2-minute setup, no credit card required.

RegulatoryAlerts Logo
RegulatoryAlerts

Automated regulatory intelligence monitoring for pharmaceutical and biotech professionals. Track FDA, EMA, and Health Canada updates seamlessly.

Product

  • Insights
  • Updates by Therapeutic Area
  • FDA Updates
  • EMA Updates
  • Pricing
  • Features
  • Request Demo

Resources

  • Integration Guides
  • Regulatory Glossary
  • EMA Timeline
  • Best Practices
  • Therapeutic Areas

Company

  • About Us
  • Blog
  • Contact
  • Security
  • Privacy Policy
  • Terms of Service

    • © 2026 RegulatoryAlerts. All rights reserved.

    Not affiliated with the FDA, EMA, or Health Canada.