Is the device intended to be used for any of the following purposes?

​for detecting the presence of, or exposure to, a sexually transmitted agent;

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

for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring;

for pre-natal screening of women in order to determine their immune status towards transmissible agents;

for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

to be used as companion diagnostics;

to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

to be used in screening, diagnosis, or staging of cancer;

for human genetic testing;

for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

for management of patients suffering from a life-threatening disease or condition;

for screening for congenital disorders in the embryo or foetus;

for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities.