Company Overview

       On September 1st 2022, Advanced Biological Laboratories Fedialis SAS (formerly ABL France SAS) merged into ABL Diagnostics S.A. (ABLD),  a worldwide leading international company, listed on Euronext Paris compartment C (ISIN FR001400AHX6), offering innovative and proprietary molecular biology assays and end-to-end solutions intended to be used for molecular detection by Polymerase Chain Reaction (PCR) – UltraGene® and for genotyping through DNA sequencing – DeepChek® (a very sensitive, robust and sustainable technology allowing precise identification of relevant genomic variations like single nucleotide polymorphisms (SNP), amino-acid mutations, quasispecies like variants of concern, already published or which will be discovered in the future, with known impact on disease prognosis, drug efficacy, pathogen activity…). 

     These molecular biology products are generating recurring revenues and cover one of the largest portfolio of microbiology applications, growing fast year after year to stick to the market needs, with a primary focus on HIV (with CE-IVD marked target-specific assays covering all relevant genes used for drug resistance assessment like reverse transcriptaseproteaseintegrase and with disruptive Whole Genome Kits), on SARS-CoV-2 (with a first version of the Whole Genome assay being CE-IVD), on Tuberculosis (with a CE-IVD marked multiplex assay targeting genes relevant for first line, second line and new-drugs resistance determination), on viral hepatitis B and C16s/18s RNA for taxonomy and microbiome analyses and other viral and bacterial targets. Please consult ABL team for further information about registration status of the ABLD’s products in your territory.

        ABLD commercializes its entire line of products on a worldwide basis throught its own sales team and through a network of exclusive distributors active on all continents. ABLD clients are academic clinical pathology labs, private reference labs and researchers willing to implement an innovative and robust microbiology content in constant expansion.

       ABLD also develops, manufactures and markets kits for clinical specimen collection – MediaChek® and digital solutions like Nadis®, an CE-marked Electronic Medical Record (EMR) system used in France in more than 200 hospitals managing patients infected by HIV or Viral Hepatitis.

      Since 2019, the activities of ABL DIAGNOSTICS have also been carried out in the United States through its wholly owned subsidiary, ABL ADVANCEDDX BIOLOGICAL LABORATORIES USA Inc.

Our Mission

ABL’s mission is to develop, manufacture and commercialize proprietary end-to-end diagnostic solutions for infectious diseases

Mohamed ERRAFYQY

Customer Relations Manager - DPO

Anh Thu FACCHIN

Customer Care Manager

Quality & Conformity

ISO 13485:2016

At ABL Diagnostics, since September 2019, we are compliant to ISO 13485:2016 and are using European ISO 13485 certified suppliers for components of our products.
 
To ensure full control about our quality standards, most of our products are produced or assembled in-house, in our laboratories in Marseille (France) or in our mother-company’s facilities in Luxembourg which received the Label “Made In Luxembourg” in June 2021.
 
We are certified ISO 13485:2016 since October 2022 with the scope: “Design, development, production, distribution, training and support of in-vitro diagnostic medical devices”. Request the certificate below.
 
Our quality standards and ISO certification allow us to offer products suitable for IVD.
 
A panel of our products are CE-IVD marked according to the European Directive 98/79/EC and are valid during the transitional period to the new EU Regulation for IVD medical devices 2017/746, up to the 25th of May 2026. 
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