IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR Kit number: EAE 0432-139-00 PDF
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR kit number: EAE 0432-139-00 PDF
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: STANDARD™ Q Ebola Zaire Ag EUAL number: EAE 0444-117-00 PDF
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: STANDARD™ Q Ebola Zaire Ag EUAL number: EAE 0444-117-00 PDF
IVD WHO EUAL Public Report for Ebola IVD: Product: OraQuick® Ebola Rapid Antigen Test Kit (cadaveric oral fluid and whole blood) EUAL number: EA 0023-021-00 PDF
IVD WHO EUAL Public Report for Ebola IVD: Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 Application number: EAE 0425-153-00 PDF
IVD WHO EUAL Public Report for Ebola IVD: Product: Xpert Ebola Assay EUAL number: EAE 0443-070-00 PDF
IVD WHO EUAL Public Report for Ebola IVD: Product: Xpert Ebola Assay EUAL number: EAE 0443-070-00 PDF
IVD WHO EUAL Public Report for EVD IVD: Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 Application number: EAE 0425-153-00 PDF
IVD WHO EUAL Public Report for Zika IVD: Product: AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit EUAL number: EAZ 0006-004-00 PDF
IVD WHO EUAL Public Report for Zika IVD: Product: careGENETM Zika Virus RT-PCR kit WHO EUAL reference number: EAZ 0009-007-00 PDF
IVD WHO EUAL Public Report for Zika IVD: Product: Liferiver Zika Virus (ZIKV) Real Time RT-PCR Kit WHO EUAL reference number: EAZ 0004-003-00 PDF
IVD WHO EUAL Public Report for Zika IVD: Product: RealStar® Zika Virus RT-PCR Kit 1.0 EUAL number: EAZ 0003-002-00 PDF
IVD WHO EUL public report for cobas MPXV Qualitative assay for use on the cobas 6800/8800, (MPXV-12647-046-00) PDF
IVD WHO EUL Public Report for COVID-19 IgM/IgG Test Kit (Colloidal Gold) EUL Number: EUL 0573-231-00 PDF
IVD WHO EUL Public Report for Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) EUL Number: EUL 0588-238-00 PDF
IVD WHO EUL Public Report for Panbio COVID-19 Ag Rapid Test Device (NASAL) EUL Number: EUL-0587-032-00
IVD WHO EUL Public Report for Panbio COVID-19 Ag Rapid Test Device (Nasopharyngeal) EUL Number: EUL-0564-032-00
IVD WHO EUL Public Report for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) EUL Number: EUL 0582-223-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Diagnovital SARS-CoV-2 Real Time PCR Kit EUL Number: EUL 0531-129-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Panbio COVID-19 Antigen Self-Test EUL Number: EUL 0692-032-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Product: 2019 Novel Coronavirus (ORF1ab, E&N genes) Nucleic Acid Test Kit (Fluorescent Prob-based Real-time PCR Assay) EUL Number: EUL 0509-197-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Product: CareGENETM COVID-19 RT-PCR Kit EUL Number: EUL 0521-113-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Product: Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit EUL Number: EUL-0486-139-00
IVD WHO EUL Public Report for SARS-CoV-2: Product: RT-PCR Kit for Detecting SARS-CoV-2 (Real-time Fluorescent PCR) EUL Number: EUL 0507-195-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Product: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent RT-RAA) EUL Number: EUL 0512-199-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: Product: STANDARD Q COVID-19 Ag Test EUL Number: EUL 0563-117-00
IVD WHO EUL Public Report for SARS-CoV-2: Product: Sure Status COVID-19 Antigen Card Test EUL Number: EUL-0590-010-00
IVD WHO EUL Public Report for SARS-CoV-2: Product: TaqPath COVID‑19 CE‑IVD RT‑PCR Kit EUL Number: EUL-0525-156-00
IVD WHO EUL Public Report for SARS-CoV-2: Product:Novel Coronavirus (2019-nCoV) Antibody Rapid Test EUL Number: EUL 0552-219-00 PDF
IVD WHO EUL Public Report for SARS-CoV-2: SARS-CoV-2 Antigen Rapid Test (Self-Testing) EUL Number: EUL 0707-021-00 PDF
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin - full assessment pathway PDF
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of human insulin approved by Stringent regualtory authorities - abridged assessment pathway PDF
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of rituximab or trastuzumab approved by stringent regulatory authorities - Abridged Assessment PDF
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products for rituximab and trastuzumab. Preparation of product dossiers in common technical document format - Full Assessment PDF
M WHO Guidelines on submission of documentation for the procedure for prequalification of biotherapeutic products or their corresponding similar biotherapeutic products approved by stringent regulatory authorities PDF
M WHO Guidelines on submission of documentation for the procedure for prequalification of similar biotherapeutic products PDF