ELISA test for the detection of Lyme disease in human serum

ELISA test for the detection of Lyme disease in human serum, 6720 tests. The designated position includes 2 sub-positions, described in detail in the technical specification - Appendix 1. To the technical offer for all designated positions - FOR THE PROOF of the relevant characteristics, the following must be attached: manufacturer's catalogs with catalog numbers and/or other documents (manuals, manufacturer's user instructions, excerpts from the manufacturer's website, etc., with catalog numbers) showing that the offered product meets the Contracting Authority's requirements set out in the technical specification. To the technical offer FOR ALL DESIGNATED POSITIONS, a copy of the Declaration of Conformity with Directive 98/79/EC / on in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices must also be attached. In accordance with the requirements of Art. 37, para. 1 of ORDINANCE No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value at which they are reimbursed, the participant must DECLARE that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list referred to in Art. 1 point 1 letter "b" of the Ordinance; there is no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months, according to information provided by the IAL; they are reimbursed in at least three EU Member States through their respective public funding systems or their respective health insurance funds. For designated positions marked as complex /with sub-positions/, participants must submit an offer for all sub-positions covered by the respective designated position, otherwise they will be excluded from the procedure.