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  1. #748122

    chun a bhrath an bhfuil oibreán tógálach i sreabhán ceirbreadhromlaigh nó i bhfuil nach bhfuil riosca ard nó amhrasta síolraithe aige;

    for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )