Division 1

The institutes listed in paragraph 2(d) shall evaluate Elisa ADV-gE tests and kits against the criteria in paragraph 2(a), (b) and (c). The competent authority in each Member State shall ensure that only Elisa ADV-gE kits that meet these standards shall be registered. The examinations listed in 2(a) and (b) must be carried out prior to approval of the test and the examination in 2(c), at least, must thereafter be carried out on each batch.