Kits for Quantitative Determination

This tender concerns the procurement of kits for quantitative determination of cytokines. The contract is for a duration of 24 months and includes two main lots. Lot 1 is for a kit for the quantitative multiplex determination of a panel of 10 cytokines (GM-CSF, TNF-alpha, IL-4, IL-6, IL-8, IFN-gamma, IL-10, IL-5, IL-2, IL-1beta) based on the use of fluorescently labeled magnetic spheres. The estimated quantity for this lot is 1400 tests. Lot 2 is for a kit for the quantitative determination of IL-17, also based on fluorescently labeled magnetic spheres, with an estimated quantity of 200 tests. A mandatory condition for participation is the completeness of the offer for each designated position; bidders must offer all nomenclature units within a position. The tender specifies that any mention of specific models, sources, processes, trademarks, types, origins, or manufacturing that could favor or eliminate certain persons or products should be interpreted as 'or equivalent'.

Suppliers must ensure that the supplied medical devices comply with the requirements of the Law on Medical Devices. They must possess a Declaration of Conformity or equivalent documents demonstrating compliance with the relevant EU Directives/Regulations, specifically Regulation (EU) 2017/745 on medical devices, Directive 93/42 EEC, or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body. A CE marking quality certificate, according to the applicable EU directive, is also required. The shelf life of the medical devices must be at least six months from the date of the acceptance protocol. Participants must submit catalogs, brochures, or information sheets with detailed product information, including all specifications and manufacturing characteristics, translated into Bulgarian.

This is a supplies contract in the health and medical services sector, with a focus on Medical Equipment and Laboratory. Located in Bulgaria, Europe, this opportunity is open to firms and consortiums, with an estimated budget of BGN 104,800.

Published through TED - Tenders Electronic Daily (EU), a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for the supply of goods in the health and medical services sector. Supply contracts typically require bidders to demonstrate product compliance with technical specifications, delivery capacity, and relevant certifications. This contract has already been awarded. The information is published for transparency and market intelligence purposes.