Public procurement notice: Contract Notice
Published: 2016-04-13
Buyer: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2016-04-18

Technical requirements: Reagents, Controls and Supplies for Haematologic Analyser Sysmex, Medonic M and Coagulometer BFT II or the Equivalent.
Part 2 Control Blood for Haematology Analysers for 3-part differentiation for Sysmex KX 21n or the equivalent;
Part 3 Control Blood for Haematological Analysers for 5-part differentiation for Sysmex XS 1 000 or the equivalent;
1. Compatible solution for dilution of haematology analyser Sysmex KX 21N and XS 1 000 or the equivalent litre 4 320;
2. Reagent for lysis for the purpose of determining 3 part differentiation compatible with haematology analyser Sysmex KX 21N or the equivalent ml 114 000;
3. Reagent without cyanide for determining haemoglobin in order to identify 5 part differentiation compatible with the haematology analyser Sysmex XS 1 000 or the equivalent ml 18 500;
4. Reagent for fluorescent staining of leukocytes in order to determine 5 part differentiation compatible to haematology analyser Sysmex XS 1 000 or the equivalent ml 1 134;
5. Lysis reagent in order to determine the 5 part differentiation compatible to haematology analyser XS 1 000 or the equivalent litre 75;
6. Alkaline detergent for cleaning, compatible with haematology analysers Sysmex KX 21N and XS 1 000 or the equivalent ml 1 000.
Part 2 Control Blood for Haematology Analysers for 3-part differentiation for Sysmex KX 21n or the equivalent.
1. Normal Level — normal level of control blood compatible with haematology analyser Sysmex KX 21N or the equivalent ml 55,2;
2. Low Level — low level of control blood compatible with haematology analyser Sysmex KX 21N or the equivalent ml 55,2;
3. High Level — high level of control blood compatible with haematology analyser Sysmex KX 21N or the equivalent ml 55,2.
Part 3 Control Blood for Haematological Analysers for 5-part differentiation for Sysmex XS 1 000 or the equivalent.
1. Normal Level — normal level of control blood compatible with haematology analyser Sysmex XS 1 000 or the equivalent ml 18;

Eligibility requirements: — Document for registered activity — DRD Form, issued by the Central Registry or an appropriate document issued by a competent authority in the country where the bidder is registered; — Valid decision on performing wholesale of medical devices issued by the Agency for Medicines and Medical Devices (Article 126 Paragraph 2 from the Law on Medicines and Medical Devices); — That procurement subject — Reagents, Controls and Supplies for Haematologic Analyser Sysmex, Medonic M and Coagulometer BFT II or the equivalent approved to be released into circulation on the territory of Republic of Macedonia in accordance with the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical devices, except for Part 5 which is not subject to registration; — Decision on registration of medical devices — Reagents, Controls and Supplies for Haematologic Analyser Sysmex, Medonic M and Coagulometer BFT II or the equivalent in the registry of medical devices available on the territory of Republic of Macedonia or Temporary approval, i.e. final approval for parallel import of medical means, according to Articles 131 and 131 of the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices, except for Section 5, which is not subject to registration.