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Pharmaceutical Processing News
News Release from: Biochrom
Edited by the Processingtalk Editorial
Team on 22 July 2004
Biochrom AAA Achieves PKU Approval
Biochrom is the first Amino Acid Analysers manufacturer to achieve this internationally recognised approval under the ISO 13485:2003 standard for its PKU diagnostic reagents
Biochrom Amino Acid Analysers are used widely for screening blood plasma samples for Phenylketonuria (PKU), a genetic disorder that prevents the normal use of protein foods and can lead to impaired brain development if not treated The IVD (In Vitro Diagnostic) Directive requires that equipment and reagents used for the in vitro diagnosis of this condition are subject to especially stringent quality controls, certified by an external "notified body"
This article was originally published on Processingtalk on 9 Jul 2003 at 8.00am (UK)
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Biochrom is proud to have achieved this certification for their reagents from the UK notified body, LRQA (Lloyds Register Quality Assurance), as part of the company's approval under the new ISO 13485:2003 standard.
The certification reference is 0890333/C.
This makes Biochrom the first AAA manufacturer to achieve this internationally recognised approval for its PKU diagnostic reagents.
The latest Biochrom 30 AAA is a compact bench-top instrument incorporating customised "load and go" applications for simplicity of operation.
The Biochrom 30 software, with graphical user interface, fully integrates instrument control and data handling functions and provides flexible data export and customised reporting. Request free introductory details about products from Biochrom ...
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