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Prequalified In Vitro Diagnostics

Prequalified In Vitro Diagnostics

The List of WHO-prequaified In Vitro Diagnostic products contains diagnostics used to diagnose a number of conditions and diseases, and that have been assessed by WHO and found to be acceptable, in principle, for procurement by UN agencies. 

General information – WHO List of Prequalified In Vitro Diagnostic Products

The WHO List of Prequalified In Vitro Diagnostic Products is updated regularly, generally with the inclusion of newly-prequalified products.

Diagnostic products are added to the list (following the voluntary participation of relevant applicants) as and when the data on such products has been assessed and evaluated, and relevant sites inspected by WHO, and considered (the time of the assessment, evaluation and inspection) to meet WHO prequalification requirements, as described elsewhere on this web site. WHO cannot represent that the listed products and manufacturing sites will continue to meet the aforesaid standards. WHO may suspend or remove products from the list based on information that may subsequently become available to it.

Please note that:

  • The list is not an exhaustive list of diagnostic products used in the treatment of HIV/AIDS, malaria or other diseases.
  • The fact that certain products and suppliers are not included in the list does not mean that if assessed, evaluated and tested, they would not be found to comply with the above-mentioned standards.
  • Inclusion in the list does not imply any approval by WHO of the products and manufacturing sites in question (which is the sole prerogative of national authorities).
  • This list may not be used by manufacturers and suppliers for commercial or promotional purposes.

Suggestions relating to procurement

  • Any UN organization intending to use the list of prequalified products for procurement should ensure that only products from the manufacturing sites mentioned in this list are supplied to it.
  • Procurement organizations using this list for procurement should perform other aspects of qualification prior to purchasing, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.
  • This list does not constitute any guarantee for the procurement of the products from the suppliers mentioned.

Disclaimer to the WHO List of Prequalified Diagnostic Products

1)  Inclusion in this list does not constitute an endorsement, or warranty of the fitness, by WHO of any product for a particular purpose, including in regard to its safety and/or efficacy.

2)  WHO does not furthermore warrant or represent that:

  • the list is complete or error free; and/or that
  • the products and manufacturing sites which have been found to meet the standards recommended by WHO, will continue to do so; and/or that
  • the products listed have obtained regulatory approval for their specified use or any other use in any country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws.

3)  In addition, WHO wishes to alert procuring agencies that the improper storage, handling and transportation of diagnostic products may affect their quality, efficacy and safety.

4)  WHO disclaims any and all liability and responsibility for any injury, death, loss, damage or other prejudice of any kind whatsoever that may arise as a result