<p>This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.</p>
<p>This document can also be applicable to accessories.</p>
<p>This document is applicable to the labels for outer and immediate containers and to the instructions for use.</p>
<p>This document does not apply to:</p>
<p>a) IVD instruments or equipment;</p>
<p>b) IVD reagents for professional use.</p>
Registration number (WIID)
79869
Scope
<p>This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.</p>
<p>This document can also be applicable to accessories.</p>
<p>This document is applicable to the labels for outer and immediate containers and to the instructions for use.</p>
<p>This document does not apply to:</p>
<p>a) IVD instruments or equipment;</p>
<p>b) IVD reagents for professional use.</p>
