ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
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Programvareprodukter og lisenser
Statens Serum Institut har brug for PKU-kort til nyfødtes screening for 25 alvorlige medfødte sygdomme i Danmark, Færøerne og Grønland. Disse kort skal være i overensstemmelse med IVD-forordningen og bestå af en filterpapirdel til blodprøver samt en demografisk del til information om mor og barn. Kontrakten har en maksimal totalværdi på 1.000.000 DKK. Tildelingskriteriet er pris, hvor kontrakten tildeles til tilbudsgiveren med den laveste pris.
About the bid
- Contact name
- Henrik Bækby Graversen
- Contact phone
- +45 32688917
- Contact email
- hebb@ssi.dk
- Address
- Artillerivej 5, 2300 København S
1. Purpose Statens Serum Institut, hereafter ‘the contracting authority’, requests the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation. The contracting authority hereby invites interested suitable companies to submit tenders for the performance of this task. The contracting authority’s suitability requirements and a description of which information and documents the companies shall submit in regard to the suitability assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk. 1.1 General description of the purchase Statens Serum Institute (SSI) carries out screening of 25 serious congenital diseases in the national newborn screening program. All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick test, where blood is spotted on a dried blood spot card (also called PKU card). The Danish PKU card consists of a filter-paper part for spotting the blood and a demographics part for information about mother and child. The Danish PKU card must be an IVD device and intended for use in newborn screening.
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Award Criteria
Description
The contracting authority will award the contract to the tenderer with the lowest price.
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See the full notice
- Contracting authority
- Statens Serum Institut
- Title
- ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
- Type
- Main code
- Supplemental codes
- Location
- Byen København
- Estimated value
- DKK 1,000,000.00