Part 2Class 3 and 4 IVD medical devices

Part 2—Class 3 and 4 IVD medical devices

Note: See section 6.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Excluded purposes</span></p></td></tr><tr><td style="width:13.24%; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:86.76%; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr><td style="width:13.24%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:86.76%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Purposes</span></p></td></tr></thead><tbody><tr><td style="width:13.24%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:86.76%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>testing specimens from the human body, other than to:</span></p><p class="Tabletext" style="margin-left:17.25pt; text-indent:-17.25pt"><span>(a)</span><span style="width:6.15pt; text-indent:0pt; display:inline-block"> </span><span>test for the presence of, or exposure to any of the following pathogenic organisms or transmissible agents:</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(i)</span><span style="width:15.11pt; text-indent:0pt; display:inline-block"> </span><span>chlamydia trachomatis;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(ii)</span><span style="width:12.33pt; text-indent:0pt; display:inline-block"> </span><span>hepatitis B virus;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(iii)</span><span style="width:9.55pt; text-indent:0pt; display:inline-block"> </span><span>hepatitis C virus;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(iv)</span><span style="width:10.11pt; text-indent:0pt; display:inline-block"> </span><span>herpes simplex virus type 1 and 2;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(v)</span><span style="width:12.89pt; text-indent:0pt; display:inline-block"> </span><span>human immunodeficiency virus type 1 and type 2;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(vi)</span><span style="width:10.11pt; text-indent:0pt; display:inline-block"> </span><span>seasonal influenza virus;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(vii)</span><span style="width:7.33pt; text-indent:0pt; display:inline-block"> </span><span>neisseria gonorrhoea;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(viii)</span><span style="width:4.55pt; text-indent:0pt; display:inline-block"> </span><span>treponema pallidum (syphilis); or</span></p><p class="Tabletext" style="margin-left:17.5pt; text-indent:-17.5pt"><span>(b)</span><span style="width:5.84pt; text-indent:0pt; display:inline-block"> </span><span>diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(i)</span><span style="width:15.11pt; text-indent:0pt; display:inline-block"> </span><span>diabetes;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(ii)</span><span style="width:12.33pt; text-indent:0pt; display:inline-block"> </span><span>kidney disease;</span></p><p class="Tabletext" style="margin-left:49.1pt; text-indent:-24.55pt"><span>(iii)</span><span style="width:9.55pt; text-indent:0pt; display:inline-block"> </span><span>cardiovascular disease; or</span></p><p class="Tabletext" style="margin-left:24.55pt; text-indent:-24.55pt"><span>(c) test for the presence of SARS-CoV-2 antigens or SARS-CoV-2 nucleic acid</span></p></td></tr></tbody></table>