Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 92

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 92
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 Plus, intended to be used in gel technique for the evaluation of the direct antiglobulin test. This test permits the differentiation of red blood cells sensitized in vivo by IgG, IgA and IgM type immunoglobulins and/or with the complement C3b, C3d and C4b fractions in human blood samples. The DG Gel® DC Scan Plus card is intended for the investigation of clinical situations where the presence of hemolysis has been established, or is suspected, to distinguish immune from nonimmune hemolytic anemia. The card can be used manually or with automated instruments of the DG Gel® System.   ​   CE mark in 2022; Approval in Brazil 2023; Approval in Australia 2023.  
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Sero-Cyte Pool Dia 0.8%, designed for routine testing for the screening of irregular antibodies, including the antigen Dia, in donors. This reagent complements the existing reagent red blood cells and allows us to reinforce our presence in markets, such as Brazil, where the identification of the antigen Dia is required by local regulations.                                                                                                                                                                                                                                                                          ​   CE mark in 2022; Approval in Brazil 2023.                              
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DG Reader NET, a single card processing platform operating with the same consumables and reagents as our fully automated systems. This product is designed to be used on our DG Gel® systems.                                                                                                                                                                                                                                                                                                                                                                                                                                   ​   CE mark in 2016; FDA 510(k) clearance in 2018; Approval in China 2023. 
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Below are the main recent developments in respect of products of our Diagnostic business unit:

●   We obtained registrations in the Chinese market for DG Reader Net, our semi-automated blood bank system to process DG gel cards and Erytra Eflexis, our flagship fully automated blood typing platform;
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●   We obtained CE mark for the Procleix ArboPlex Assay 4-in-1 NAT for arbovirus screening. This assay is an in vitro nucleic acid test that detects four types of arboviruses spread through mosquito vectors: chikungunya, dengue, West Nile and Zika viruses. Arboviruses are a growing threat, with changes in climate and increasing global connectivity making the geographic spread more prevalent. This is the first CE mark under the IVDR for an acid