Recent Activities

July 2017: NRL Accredited as a WHO Prequalification Evaluating Laboratory  

On the 25 July 2017, NRL was accepted as a WHO Prequalification Evaluating Laboratory allowing NRL to independently evaluate in vitro diagnostic devices (IVDs) for HIV, HCV and HBV Nucleic Acid Testing and HIV, HCV, HBV and Syphilis serology. The aim of the WHO Prequalification of IVDs is to promote and facilitate access to safe, appropriate and affordable IVDs of acceptable quality. Products submitted for prequalification are subjected to a comprehensive, standardized assessment to determine if WHO prequalification requirements are met. The assessment comprises three components:

  • Review of a product dossier;

  • evaluation of performance and operational characteristics; and

  • manufacturing site(s) inspection.

 

As part of a small selection of laboratories qualified to undertake this work, NRL looks forward to offering this service.

Contact Us

 Address: 4th Floor, Healy BuildinNRL

4th Floor, Healy Building

41 Victoria Parade

Fitzroy VIC 3065

Australia

Fax: +61 3 9418 1155

Phone: +61 3 9418 1111

Email: info@nrlquality.org.au

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NRL is designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections