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Blood typing for IVDR

Validation of ABO, RH, Duffy and Kell blood group analyzes prior to IVDR approval.

Purpose

The regulation for in vitro diagnostics (IVDR – EU 2017/746) aims to ensure and streamline diagnostic tests on the European market. The IVDR was adopted in April 2017 and became fully applicable on May 26, 2022. All new IVD devices must therefore meet the requirements of the IVDR before being placed on the market. Likewise, IVD devices that were on the market before 26 May 2022 must be validated and approved in accordance with the IVDR.

The IVDR has resulted in stricter classification rules and thus also a greater need for Notified Bodies (NB). All IVD units require approval from NB. At RISE, we can validate IVD products within blood typing that belong to class D, prior to approval in accordance with the IVDR.

Method

Identification of AB0-RH, Duffy and Kell systems by agglutination.

Delivery

The result is reported in a validation report with a compilation of results.

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Service

Evaluation of blood grouping analyses. We can validate AB0, RH, Duffy and Kell systems for IVDR.

Delivery level

Accredited

Price

Price on tender

Contact person

Hardis Rabe

Forskare

+46 10 516 60 38

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Contact person

Karin Agrenius

Projektledare

+46 10 516 59 42

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