<p>This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.</p>
<p>This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.</p>
<p>This document can also be applicable to accessories.</p>
<p>This document does not apply to:</p>
<p>a) instructions for instrument servicing or repair;</p>
<p>b) IVD reagents, including calibrators and control materials for use in control of the reagent;</p>
<p>c) IVD instruments for self-testing.</p>
Registration number (WIID)
79868
Scope
<p>This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.</p>
<p>This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.</p>
<p>This document can also be applicable to accessories.</p>
<p>This document does not apply to:</p>
<p>a) instructions for instrument servicing or repair;</p>
<p>b) IVD reagents, including calibrators and control materials for use in control of the reagent;</p>
<p>c) IVD instruments for self-testing.</p>
