Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
Borderline and Classification Work Group â Introduction - TOPRA
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Manual of Decisions Content<br />
1. Medical device/in vitro diagnostic medical device – medical<br />
intended purpose<br />
– Light box indicated to treat seasonal affective disorder (S.A.D)<br />
– AB0 <strong>and</strong> Rhesus (D) blood grouping intended for diet purposes<br />
2. <strong>Borderline</strong> in vitro diagnostic medical device<br />
– Sample receptacles <strong>and</strong> sampling devices which are intended to be<br />
used for<br />
– the collection by the lay user of samples, which are subsequently<br />
examined by<br />
– third persons<br />
– CE labelled microscopes slides<br />
– Single or multiple channel pipettes<br />
The Organisation for Professionals in Regulatory Affairs<br />
8
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