News
4 November, 2025 - 10:16 (CET)
Information note
IVD
WHO’s Prequalification of In Vitro Diagnostics
During the week of 27–31 October 2025, the World Health Organization (WHO) published updates to several WHO’s Public Assessment Reports (WHOPARs) on its In Vitro Diagnostics (IVDs) assessment website. These updates reflect post-prequalification changes that were formally notified to WHO, reviewed, and approved to ensure the continued quality, safety, and performance of the prequalified products.
The updated WHOPARs are accessible through the following links:
Abbott RealTime HCV (PQDx 0450-027-00)
Abbott RealTime High Risk HPV (PQDx 0455-180-00)
Abbott RealTime HIV-1 (m2000sp) (PQDx 0145-027-00)
Abbott RealTime HIV-1 (m24sp) (PQDx 0083-027-00)
Abbott RealTime HIV-1 (Manual) (PQDx 0146-027-00)
ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (PQDx 0141-051-00)