The IVD (In Vitro Diagnostic) Directive requires that equipment and reagents used for the in vitro diagnosis of this condition are subject to stringent quality controls
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.
Biochrom reports that it has achieved this certification for its 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.
